Model protocol for organ donation

This protocol describes the procedure for post-mortem organ donation. You will find a description of all steps and the actions that must take place here.

Diagram 1 shows the process of post-mortem organ donation. The diagram shows at what moment which steps apply, who is responsible for which step, and what each step entails. The steps are explained in the chapters.

The diagram distinguishes between the DBD procedure and the DCD procedure. Different steps are taken for each procedure.

• A DBD procedure begins with the determination of death.
• In a DCD procedure, death is only determined in the final phase.

The registration of the donor and the organization of logistics are the same for both procedures. These tasks are described in chapter 7.

The donation process starts with the identification of a potential donor. This chapter provides guidance for this. The chapter describes the criteria and contraindications for organ donation. The colored box in Scheme 2 indicates which step is described in this chapter.

If a doctor decides to stop a patient's life-sustaining treatment and it is expected that the patient will die, the possibility of organ donation must be considered. Whether donation is possible depends on whether there are any contraindications. A distinction is made between general contraindications, relative contraindications, and organ-specific contraindications.

2.2.1 General contraindications

The general contraindications for organ donation are:

• The patient's identity is unknown
• < 24 hours of adequately treated sepsis
• Active tuberculosis
• An active infection with rabies, herpes zoster, or rubella
• Anencephaly

In all these cases, organ donation is excluded.

2.2.2 Relative contraindications

The relative contraindications are:

• HIV
• Chronic/active untreatable infections, for example Q fever
• Hepatitis B (download the national protocol)
• Malignancies
• An unknown cause of death

Note: In the case of malignancies, donation is sometimes possible, namely:

• For some primary, non-metastasized brain tumors.
• If the malignancy has been treated curatively.

In case of a relative contraindication, consult the Organ Center (071 579 57 95) or the on-duty ODC.

2.2.3 Organ-specific contraindications and age criteria

Organs may be excluded from donation due to underlying diseases or failure to meet age criteria.

Table 1 shows the contraindications and age criteria per organ. The age criteria per organ differ for a DBD and a DCD procedure.

Table 1: Organ-specific contraindications and age criteria

In the Netherlands, children can also be organ donors. Children aged 12 and older can register in the Donor Register, and children under 12 can be donors if their parents give consent.

Therefore, consult the Donor Register for children aged 12 and older, and for any potential organ donor under 18, contact the Organ Center (071 579 57 95) or the on-duty ODC. Do this before speaking with the parents/family. See 3.4 for more information about children as donors or go to the Protocol Child as donor.

In case of doubt about a contraindication or doubt about a patient's suitability for organ donation, contact the Organ Center via 071 579 57 95, or the on-duty ODC.

If there are no general contraindications, consult the Donor Register and then contact the Organ Center via 071 579 57 95, or the on-duty ODC.

If organ donation is not possible for a patient, check chapter 2 of the Model Protocol for Tissue Donation to see if the patient may be able to donate tissues. The tissue donation procedure can be started after the patient has passed away.

View the national encompassing protocol for hepatitis B here.

Download the national protocol

2.8.1 Introduction

Due to the introduction of direct-acting antiviral (DAA) therapy, the treatment of hepatitis C virus (HCV) has greatly improved, with >95% effectiveness. As a result, there are more possibilities to transplant HCV-positive organs (kidneys, hearts, lungs, and livers). Transplantation from HCV-positive donors to HCV-negative recipients has proven to be safe, which can shorten waiting lists and reduce waiting list mortality and morbidity.

This protocol serves as a guideline for the diagnostics and treatment of HCV after solid organ transplantation (SOT), in the case of an HCV-positive donor and an HCV-negative recipient.

2.8.2 HCV-positive donors - categories

There are three categories of HCV-positive donors, with different interpretations and recommendations. The following sections focus on category 3, and category 2 if the HCV PCR result is positive.

NB: If there are indications that the donor has failed DAA therapy, this protocol does not apply and the organ should not be accepted.

2.8.3 Considerations for accepting an HCV+ organ

The probability that the recipient becomes positive after transplantation in a donor positive/recipient negative (D+/R-) HCV setting is nearly 100% for all types of organs. The primary treating physician must make a balanced decision, taking into account factors such as organ quality, potential co-infections, the possibility of HCV DAA therapy post-transplantation, and waiting list morbidity and mortality. In the case of a liver, these should in principle not be accepted unless the presence of cirrhosis/fibrosis can be ruled out by a gastroenterologist.

2.8.4 Informed consent

It is strongly preferred to request patient consent for the acceptance of a potential anti-HCV positive donor during the preparation phase or electively. It must be discussed that the probability of a recipient becoming positive in a D+/R- HCV setting is nearly 100%, but that treatment for this is successful. It is advised against requesting consent at the time of an organ offer.

2.8.5 Diagnostics

As previously described, in a D+/R- HCV positive setting, the probability that a recipient becomes HCV positive is nearly 100%, and prophylactic treatment can be considered without plasma HCV PCR. If one wishes to confirm HCV infection in the recipient, a plasma HCV PCR can be collected from the recipient between day 3 and 5 post-transplantation. If the HCV PCR is negative, determine the HCV PCR again on day 7. 90% of HCV recipients are viremic within 7 days. In these cases, one can still start pre-emptively. If the HCV PCR is still negative on day 7, repeat weekly until week 4. If the PCR is negative after week 4, an HCV infection in the recipient is highly unlikely. Consult with a virologist, infectious disease specialist, and/or gastroenterologist regarding follow-up diagnostics.

2.8.6 Treatment

Treatment takes place after consultation with a virologist, infectious disease specialist, and/or gastroenterologist.

Timely treatment should take place as described below to prevent complications such as acute hepatitis and non-hepatic complications such as acute HCV-related glomerulonephritis, acute pancreatitis, acute cellular rejection, and vasculopathy.

Monitor the effect of treatment using HCV PCR at the end of treatment (EOT). In addition, HCV PCR should be performed at week 12 (SVR12) and week 24 (SVR24) after the end of treatment. Consult an infectious disease specialist/gastroenterologist and/or virologist if the EOT measurement or SVR measurements prove to be positive.

2.8.8 Considerations for renal impairment, hepatic impairment, and DAA interactions

In HCV patients with chronic renal insufficiency, including patients with eGFR <30 ml/min and patients on hemodialysis, DAAs can be prescribed according to recommendations without dose adjustment.

For interactions, see www.hep-druginteractions.org for the most up-to-date advice, in addition to the tables in the EASL Guideline with interactions of DAAs with common co-medication.

This guideline specifically addresses the following interactions:

This chapter discusses the procedure for consulting the Donor Register:

• Who is allowed to do this, and when and how (3.1)?
• What do the different registrations mean?
• Per type of registration: what is expected of the official? Distinction between competent patients (3.2), incompetent patients (3.3) and children (3.4).
• What are the guidelines for an unnatural death (3.5).
• When the physician may begin preparatory procedures for a potential organ donation (3.6)?

3.1.1 When to consult?

The Wod (Organ Donation Act) requires physicians in hospitals to always consult the Donor Register if a patient:

• Is suitable as an organ and/or tissue donor and there is a reasonable chance that they will die in the foreseeable future or
• Is suitable as a tissue donor and has just passed away.

Does a patient die outside the hospital and are you involved as a general practitioner or other extramural physician? Then it is your professional responsibility to consult the Donor Register.

Consult the Donor Register before discussing donation with the family.

Living will

The Donor Register must also be consulted if another living will has been found for the patient. This is necessary to check whether the living will does not conflict with the registration in the Donor Register. You can read more about this in 3.1.2.

The Donor Register does not need to be consulted in these cases:

• The patient does not meet the criteria for organ and tissue donation or there are general contraindications. See also:
  • Organ donor identification
  • Tissue donor identification
  • In case of doubt about suitability, call the Organ Center: 071 579 57 95.
• The patient is under 12 years of age. Special rules for consent apply in this case (see 3.4).
• The identity is unknown and it is therefore not possible to consult the register. Donation is not permitted in this case.
• The potential donor died more than 24 hours ago. Donation is no longer possible in this case.

The official can consult the Donor Register by calling the Organ Center: 071 579 57 95.

The Organ Center acts as an intermediary for consulting the register. The official cannot look directly into the Donor Register.

The following information is required to consult the Donor Register:

Requesting official

• Name (if applicable, name of the employee calling on behalf of the official for consultation)
• Discipline
• BIG registration number
• Telephone number at which this contact person can be reached
• Institution - Name - Address

Patient

• BSN (Citizen Service Number)
• Initials - Prefixes - Surname
• Date of birth
• Gender
• Address

During the telephone consultation, the Organ Center employee may first ask a few medical questions to rule out the most common contraindications for donation. This takes about 5 minutes.

Are there no contraindications present? Then the employee will consult the Donor Register and provide the result by telephone. In doing so, the employee will also indicate for which organs and/or tissues consent has been given and for which it has not.

During the procedure, the official can (at the request of the family) request a printout of the declaration of will from the Organ Center at any time. The hospital's donation coordinator can retrieve the result of the consultation via NovaNORD. This information can be added to the patient file if desired.

Conversations with the Organ Center are recorded for training purposes, to be able to listen back to the conversation, and for archiving.

What the step after consulting the Donor Register is depends on the result of the consultation and on the competence and age of the patient.

• Was the patient 12 years or older at the time of death? And were they competent at the time of registration? Then follow the flowchart in 3.2.1.
• In 3.2.2 through 3.2.7 you will find the steps per registration.
• Was the patient incompetent at the time of registration? Read the procedure in 3.3.
• Was the patient younger than 18 years at the time of death? Read the (additional) guidelines in 3.4.

Is the patient registered in the Donor Register as having 'no objection' to donation? This means that the donation of tissues and organs for the purpose of transplantation is permitted. No additional consent is required. However, the official must inform the next of kin about how this registration came about.

The registration is legally valid if the patient was competent at the time of registration. Read in 3.3 what to do if the patient was incompetent at the time of registration.

Principles for the conversation

The principles for the conversation with the next of kin are described in Chapter 4. The conversation must take place before the donation. The official can use the information in the following box.

Is the patient registered in the Donor Register as 'yes, I give permission for donation' and is this registration legally valid? Then this means that the removal of tissues and organs for the purpose of transplantation is permitted. No additional consent is required. However, the official must inform the next of kin about how this consent was established. The registration is legally valid if the patient was 12 years of age or older and mentally competent at the time of registration.

• Read in 3.3 what to do if the patient was incompetent at the time of registration.

Specifics for specific organs or tissues

• Has the patient excluded certain organs and tissues from the consent for donation? Then no donation of these organs and tissues will take place. This also does not happen if the surviving relatives up to the 2nd degree indicate that they would like to give permission for this.
• At the time of registration, were there tissues or organs that could not yet be transplanted then but can be now? If so, ask the surviving relatives for additional consent for the donation of those organs or tissues.

Example: Previously, only the cornea was transplanted; now, other parts of the eye are also transplanted. The patient only gave permission for the transplantation of the cornea during their registration. Therefore, additional consent must be requested from the surviving relatives for the transplantation of eye tissue.

Is the patient registered in the Donor Register as 'no' and is this registration legally valid? Then this means that they consciously chose not to give consent for donation. In that case, no donation will take place. However, the official must inform the patient's next of kin about this registration. The registration is legally valid if the patient was 12 years or older and mentally competent at the time of registration.

Read in 3.3 what to do if the patient was incompetent at the time of registration.

Donation never permitted

With this type of registration, donation is under no circumstances permitted, not even if the patient is 12 to 16 years old and the parents exercising parental authority or the guardian have a different wish.

Has the patient registered in the Donor Register that they leave the decision regarding donation to their surviving relatives and is this registration legally valid? Then the official must inform the patient's next of kin about this registration. They must also ask the surviving relatives up to the 2nd degree for consent for donation. The registration is legally valid if the patient was 12 years or older and mentally competent at the time of registration.

Read in 3.3 what to do if the patient was incompetent at the time of registration.

Principles for the conversation

For the conversation with the surviving relatives, the principles described in chapter 4. In 4.6 and 4.7 describes how the official must request consent, which surviving relatives have decision-making authority, and how to act if these relatives disagree among themselves.

What if it is not possible to reach the surviving relatives (in time) or if there are no surviving relatives?

Is it not possible to reach any of the surviving relatives? Then the official will try to postpone the donation until someone has been reached. In 4.5 are the steps the official takes to reach the surviving relatives.

Until the surviving relatives have been reached, the official may already perform preparatory actions for the donation, as described in 3.6.

Can the official not reach any of the surviving relatives? Or can the donation no longer be postponed? Then there is no consent and no donation takes place. After all, asking for consent from the surviving relatives is a mandatory part of the procedure in this case. In addition, the official can also obtain information via the surviving relatives about the patient's medical and social history, including their mental capacity.

Are there no surviving relatives up to the 2nd degree still alive? Then donation is not permitted. There is then no consent for donation.

Has the patient registered in the Donor Register that they leave the decision regarding donation to a specific person and is this registration legally valid?

Then the official must inform that person about the registration and ask them for consent for donation. If applicable, the official must also inform other next of kin about this registration. The registration is legally valid if the patient was 12 years or older and mentally capable at the time of registration.

Read in 3.3 what to do if the patient was incompetent at the time of registration.

Principles for the conversation

For the conversation with the designated person, the principles described in apply.chapter 4. In 3.6 contain the guidelines for requesting consent for donation.

Does consulting the Donor Register reveal that the registration in question is blocked? Or is there no registration present? In that case, the official must inform the patient's relatives about this and explain to them how this can happen. The official can use the information in the box below for this purpose.

In this case, the official must make a reasonable effort to see if the patient has recorded their decision regarding donation in another way. If no other declarations are present, then no choice by the patient is known. This choice can therefore not serve as a starting point for the conversation with the relatives. There is also no consent for donation. Therefore, the official must ask for consent from the surviving relatives up to the 2nd degree.

Sometimes there may be suspicions that the patient was mentally incapacitated during (a part of) their life. This may become apparent, among other things, from the conversation with the relatives, from the medical file, or from other available information, for example about a stay in a residential facility for people with an intellectual disability. Was the patient mentally incapacitated at the time of registration in the Donor Register? Then, since the amendment of the Wod on July 1, 2020, they can sometimes still be a donor. Therefore, the official takes the following steps in case of suspected mental incapacity.

3.3.1. Verifying whether the patient was mentally incapacitated at the time of registration

First of all, the official verifies whether the patient was actually mentally incapacitated during (a part of) their life. To do this, they consult various sources. Determining mental (in)capacity is considered a medical skill: it is part of general medical practice.

If the patient was legally incompetent during (part of) their life, the official verifies whether the registration in the Donor Register is valid. To do this, they ask the Donor Register when and by whom the registration was made.

The registration is valid if:

1. The patient made it themselves at a time when they were 12 years or older and legally competent, or
2. The patient was registered as 'no objection' at a time when they were legally competent, or
3. A legal representative of the patient made the registration at a time when the patient was 18 years or older and legally incompetent.

In the first 2 cases, the official may proceed as if the patient had been legally competent their entire life. See 3.2.

In the third case, the official follows the procedure described in:

• 3.3.3 and 3.3.4: if the donation discussion takes place before the patient's death (organ donation)
• 3.3.5 and 3.3.6 :if the donation discussion takes place after the patient's death (tissue donation)

The registration is not valid if:

1. The patient made the registration themselves during a period when they were legally incompetent. Or:
2. The patient was registered as 'no objection' during a period when they were legally incompetent.

If the registration is invalid, it cannot serve as a starting point for the conversation with the next of kin. The official must then request consent for donation. The same applies if there is no registration present.

To whom the official must request that consent depends on whether the conversation takes place before the patient's death (organ donation) or after the patient's death (tissue donation). See the following sections for this.

Does the patient die in the hospital and are they suitable as an organ donor and possibly also as a tissue donor? Then the official conducts the donation conversation shortly before the patient has actually died. With whom they conduct this conversation and whether they must request consent for donation therein, you can see in the following flowchart.

As shown in the flowchart in 3.3.3 , the follow-up steps for incapacitated patients depend on who made the registration and when. The various situations are explained in more detail below.

1. The registration was made by a legal representative of the patient

A legal representative (for example, a guardian, mentor, or authorized representative) can record the patient's choice in the Donor Register on their behalf. Did a legal representative do this during the time the patient was incapacitated? And is the patient 18 years or older at the time of death? Then this registration is valid. The official must then discuss the registration with the legal representative and/or the next of kin. The following applies:

• Is the patient registered as 'yes'? Then the official must ask the legal representative if they confirm this registration. If yes, then the donation can proceed. If no, then no donation takes place.
• Is the legal representative unreachable? Then the official can ask the next of kin up to the 2nd degree for confirmation. If they confirm the registration, then the donation can proceed. If they do not confirm the registration or if there are no next of kin up to the 2nd degree reachable? Then no donation takes place.
• Is the patient registered as 'decision left to the next of kin'? Then the official must request consent for donation from the next of kin up to the 2nd degree. See 3.2.5.
• Is the patient registered as 'decision left to a specific person'? Then the official must request consent for donation from the designated person. See 3.2.6. Incidentally, a legal representative may also have designated themselves as the specific person who may decide on the donation.
• Is the patient registered as 'no'? Then no donation takes place. The official informs the legal representative and the next of kin about this.

2. The registration was made by the patient themselves at a time when they were incapacitated

Has the official checked the date of registration with the Donor Register/Organ Center? And was the patient incapacitated on that date? Then this registration is invalid. The official must then request consent for donation from the legal representative. If they give consent, then the donation can proceed. If they do not give consent, then no donation takes place.

Is the legal representative unreachable? Then the official can request consent from the next of kin up to the 2nd degree. If they give consent, the donation can proceed. If they do not give consent or if no next of kin up to the 2nd degree are reachable, then no donation takes place.

3. The patient is registered as ‘no objection’ from a time when they were legally incompetent

The same procedure applies here as in point 2.

4. There is a block in the Donor Register or there is no registration present

The same procedure applies here as in point 2.

If a patient is only suitable as a tissue donor, the official conducts the donation discussion after the patient has passed away. The legal representative no longer has decision-making authority at that point. Therefore, the official conducts the donation discussion with the next of kin up to the 2nd degree. What is discussed with them can be seen in the following flowchart:

As shown in the flowchart in 3.3.5 , the follow-up steps for incapacitated patients depend on who made the registration and when. The various situations are explained in more detail below.

1. The registration was made by a legal representative of the patient

A legal representative (for example, a guardian, mentor, or authorized representative) can record the patient's choice in the Donor Register on their behalf. Did a legal representative do this during a time when the patient was legally incompetent? And is the patient 18 years or older at the time of death? Then this registration is valid.

The official must then discuss the registration with the next of kin up to the 2nd degree. They cannot discuss this with the legal representative, because the latter no longer has decision-making authority after the patient's death.

The following applies to the discussion with the next of kin:

• Is the patient registered as ‘yes’? Then the official must ask the next of kin if they confirm this registration. If so, the donation can proceed. Do they not confirm the registration or are there no next of kin up to the 2nd degree reachable? Then no donation takes place.
• Is the patient registered as 'decision left to the next of kin'? Then the official must request consent for donation from the next of kin up to the 2nd degree. See 3.2.5.
• Is the patient registered as ‘decision left to a specific person’? Then the official must request consent for donation from that designated person. See3.2.6.
• Is the patient registered as ‘no’? Then no donation takes place. The official informs the next of kin about this.

2. The registration was made by the patient during a time when they were legally incompetent

Has the official checked the date of registration with the Donor Register/Organ Center? And was the patient legally incompetent on that date? Or was the patient legally incompetent their entire life? Then this registration is invalid. The official must then request consent for donation from the next of kin up to the 2nd degree. If they give consent, the donation can proceed. If they do not give consent or if no next of kin up to the 2nd degree are reachable, then no donation takes place.

3. The patient is registered as ‘no objection’ from a time when they were legally incompetent

The same procedure applies here as in point 2.

4. There is a block in the Donor Register or there is no registration present

The same procedure applies here as in point 2.

If the patient is younger than 18 at the time of death, special rules apply to donation. A distinction is made between children under 12, children aged 12 to 15, and children aged 16 and older.Look here for the protocol Child as donor.

Can the attending physician not issue a declaration of natural death? Then organ or tissue donation is still a possibility. However, permission from the public prosecutor is required.

If organ donation is a possibility, preparatory actions for the donation may be performed before the potential donor has passed away. The purpose of this is to keep the organs suitable for transplantation. Below is what preparatory actions are and which conditions apply to them. These rules come from the Wod (Organ Donation Act).

3.6.1 What are preparatory actions?

The preparatory actions for organ donation are:

• Conducting examinations that are necessary in preparation for the donation.
• Starting or maintaining artificial ventilation.
• Artificially maintaining blood circulation.
• Taking other measures that are necessary to keep the organs suitable for donation.

In concrete terms, this means, for example, that a patient may be intubated to make organ donation possible. This is only permitted if the conditions below are met.

3.6.2 When may preparatory actions be started?

The physician may start the preparatory actions if all of the following conditions are met:

• The Donor Register has been consulted.
  • If the patient is registered as 'yes' or 'no objection', preparatory actions may be started immediately.
  • If the patient is registered as 'No', no preparatory procedures may be performed. Donation is then not applicable.
  • If the patient has left the choice to the next of kin or a specific person, preparatory procedures may be started while awaiting the conversation with the next of kin or the specific person.
  • If there is a block in the Donor Register or if there is no registration for the patient, preparatory procedures may be started while awaiting the conversation with the next of kin.
  • It is medically futile to continue treating the patient.
• The decision to withdraw treatment must have been made before any procedures are performed that are intended solely for the donation.
• The patient will die within the foreseeable future.
• The preparatory procedures do not conflict with the medical treatment.
• The preparatory procedures cannot be delayed until after death.
• The family has not objected to the preparatory procedures. If the family has not yet been reached, preparatory procedures may be started.

After consulting the Donor Register, a conversation always takes place with the patient's next of kin regarding the registration in the Donor Register. We call this conversation the initial part of the donation conversation.
You will find here:

• Principles for this conversation and for interacting with the next of kin. These principles apply to all conversations described in 3.2 through 3.4.
• Information about who conducts the conversation (4.2), with which next of kin and surviving relatives the conversation takes place (4.5 through 4.7)
• How the official can deal with any objections to the registration or the donation (4.10 and 4.11).

Please note:

• This chapter is partly based on the Quality Standard for Donation, which was developed in the context of the amendment to the Organ Donation Act (Wod) – effective July 1, 2020. All physicians are required to adhere to this standard.
• This chapter also discusses tissue donation, as the conversation with next of kin regarding organ donation is similar to that regarding tissue donation. Sometimes the conversation covers both tissue and organ donation.
• All sections in this chapter are an elaboration of the Organ Donation Act (Wod) and are therefore normative. They may not be deviated from.

Diagram 4 shows which step in the organ donation process this chapter describes.

Dealing with next of kin

The starting point for the donation conversation and the interaction with next of kin is to honor the patient's wishes as much as possible. In principle, the patient's registration in the Donor Register is leading.

The official conducting the conversation with the next of kin makes every effort to ensure the patient's registered wish is carried out. They always discuss the registration with the next of kin. There is space and time for them to respond to this.

If, according to the next of kin, the registration does not correspond to the patient's actual wishes, the official enters into a dialogue with them to determine if that is plausible. In doing so, the official tries as much as possible to reach an agreement with the next of kin.

Please note:

• If a patient is registered as 'No, I do not give consent,' the next of kin cannot change this conclusion. In that case, no donation takes place.
• Has the patient excluded certain organs or tissues from donation? Then the next of kin cannot change this either. In that case, no donation of the relevant organs or tissues takes place.

The hospital designates officials from one or more professional groups who are authorized to conduct the donation conversation. The hospital records this in afillable document.

The official who engages in the conversation about donation with the next of kin is there solely for the patient and their next of kin. The standard is that this official has no involvement whatsoever with patients on the waiting list for an organ and/or tissue transplant. If the next of kin wish, it is possible to ask other professionals to join the conversation. The official can also actively point out this possibility to the next of kin. Examples include a social worker, a psychologist, or a spiritual counselor.

In addition, other physicians or specialists can also provide support during the conversation. To be able to provide good information about donation, it is important to have a physician present at the donation conversation who has completed the 'Communication regarding Donation' training or who has experience in discussing donation. For organ donation, the latter is mandatory.

The conversation with the next of kin about donation generally takes place after the 'bad news conversation.' In the bad news conversation, the next of kin have been informed that the patient is expected to pass away shortly (whether or not after the cessation of treatment), or that the patient has already passed away (in the case of tissue donation).

Only after the next of kin have been informed about this can the conversation regarding a potential donation take place. Sometimes, the next of kin bring up donation themselves during the 'bad news' conversation.

The conversation only takes place if there are no contraindications and there is a reasonable presumption that the patient's organs and/or tissues are suitable for donation (see Chapter 2). If that is not the case, no donation conversation will take place, but the surviving relatives will be informed of this out of consideration for due care.

Before the donation interview takes place, the official must have consulted the Donor Register.

In case of doubt regarding suitability or questions about the donation procedure in general, the official can always contact the Organ Center via071 579 57 95In the event of organ donation, the Organ Center will connect the official to the on-duty ODC if necessary.

No donation can take place without the registration in the Donor Register having been discussed with the patient's next of kin. The purpose of this conversation is to inform the next of kin about the registration regarding donation. The goal is to help the next of kin find peace with the final decision, whatever that may be.

During the conversation with the next of kin, the official discusses the outcome of the consultation of the Donor Register and – if applicable – the remainder of the procedure. The official may also provide information about the procedure (in part) in writing, but never as a substitute for the verbal information. The written/digital information is intended for reference or to be shared with next of kin who were unable to attend the conversation.

Sometimes the official must also explicitly ask for consent for donation during the conversation. This is only necessary in certain cases, for example, if the patient has explicitly indicated this in the Donor Register. You can read exactly when this is necessary in3.2 through 3.4. In 4.6You can find the procedure for when permission is required.

In all cases – regardless of whether consent is required or not – the conversation with the next of kin is a dialogue. The official reports what has been registered and how that registration came about. The next of kin are given the opportunity to respond to this and to ask questions. In4.10 and 4.11it is explained how the official can handle any objections from the surviving relatives regarding the registration or the donation.

Do the next of kin have many questions? And is the official unable to answer them? Then it is possible to involve another professional with expertise in the field of donation in the conversation. The official can reach them via the Organ Centre (071 579 57 95).

If the next of kin wish to do so, they may make an audio recording of the conversation regarding the registration (and the donation) for personal use. If they wish to do so, they must inform the official in advance. Under no circumstances may the next of kin or others film the conversation.

Which next of kin the official should consult regarding the registration depends on the content of the conversation. The Wod makes a distinction in this regard.

Does the official only need to discuss the registration in the Donor Register and not ask for consent for donation, due to a ‘yes’ or ‘no objection’ registration? In that case, the official can conduct the conversation about the registration with a ‘next of kin’ of the patient. This can be anyone who played a (significant) role in the patient’s life and therefore knew the patient well and was actively involved in their life. Whether the person present at the hospital falls under this definition is for the official to determine based on their professional judgment.

Must the official ask the next of kin for consent for donation in cases of a 'decision left to next of kin' registration, legal incapacity, no registration, a block in the registry, or a registration of a minor? In that case, they must conduct the conversation with next of kin up to the second degree. According to the Wod (Organ Donation Act), only they are authorized to make the decision. See4.6for more information.

Is it necessary to ask for consent for donation from next of kin up to the second degree or from a specific person, such as in cases of ‘decision left to next of kin’, ‘decision left to a specific person’, legal incapacity, no registration, a block in the register, or a registration by a minor? In these cases, the official explains at the beginning of the conversation how the registration was established and what it means. Subsequently, they ask the question regarding consent.

Multiple people may be present during this conversation. The official engages in a dialogue with them and provides the information they need to make an informed decision. They may also provide this information in writing, so that the surviving relatives or the designated person can read through it at their own pace. Afterwards, the official gives those authorized to make the decision time to reflect and let the information sink in. This may mean resuming the conversation at a later time to hear the decision. It is of great importance that the surviving relatives are given the time to process all information regarding the (impending) death and potential organ and/or tissue donation.

At the end of the conversation, the official summarizes what has been discussed and states whether or not consent for donation has been given. They also inform the authorized decision-makers that consent can be withdrawn until the moment the patient is in the operating room/mortuary and the donation of organs or tissues has begun. This information is also provided to them in writing.

The Wod states that only next of kin up to the 2nd degree are authorized to grant consent for donation (for those lacking legal capacity and children: see3.3 and 3.4). Also, only surviving relatives have the right to object to a ‘no objection’ or ‘yes’ registration, or to the donation itself (see4.10 and 4.11The following categories are included among the surviving relatives:

1. Spouse, registered partner, or other life partner of the patient.
2. Adult blood relatives up to the 2nd degree: (adopted) children, (adopted) parents, brothers, sisters, grandparents, and grandchildren.
3. Adult relatives up to the 2nd degree: children of the spouse (or registered partner), parents-in-law, grandparents-in-law, brothers-in-law, sisters-in-law, sons-in-law, daughters-in-law, and step-grandchildren.

The order above determines the decision-making authority. This means the official will first contact a person from category 1 (if available). If they succeed in reaching this person, the choice made by that person applies. The official then does not need to seek permission from a person in a 'subsequent' category.

If the patient has no next of kin in category 1, or if they cannot be reached, the official proceeds to category 2, and so on. The official must make reasonable efforts to reach the persons in the relevant categories. However, they are not required to reach all next of kin within each category.

Under the Wod, blood relatives and relatives by marriage in the third degree are not permitted to give consent for donation.

What if the surviving relatives do not agree with each other?

If decision-making authority lies with multiple people within the same category (see the preceding text for the order of priority) and they remain unable to reach an agreement after extensive consultation, the official may propose involving an outsider, such as a social worker or a spiritual counselor, in the discussion. If there is still no consensus regarding consent for donation, the official must terminate the procedure.

If there is consent for organ donation, or if the next of kin would like more information about organ donation, it is advised to discuss the following in any case:

• Further research must determine which organs (and tissues) are suitable.
• State that the assessment of organ suitability is focused on the interests of the recipients and not on the recovery of the donor.
• Provide a realistic estimate of the time the donation procedure takes. If the procedure is urgent, be clear about that, but also indicate that procedures can take longer (between 10 and 24 hours) due to the required level of care.
• Please be assured that the patient will be treated with respect and that we will provide as much comfort as possible.
• State that the deceased can be laid out and buried or cremated in the usual manner.
• In the event of an unnatural death: indicate that the permission of the public prosecutor is required for the removal of organs and the release of the body.
• Describe the preparatory actions that must be taken (specifically those that cannot wait, such as intubation/ventilation and stabilization).
• Regarding DBD (Donation after Brain Death): provide an explanation of the legally required brain death tests.
• For DCD: provide an explanation of the policy and the procedure for terminating treatment.

Call an ODC via the Organ Center (071 579 57 95) if the family needs more information. Inform the family that the ODC is on its way.

If consent for tissue donation has been given, or if the family would like more information about this, the advice is to discuss the topics you read in the tissue donation procedure (Chapter 5).

The donation conversation may reveal that the next of kin object to the nature of the patient's registration in the Donor Register. In that case, the following procedure applies.

If there is a registration of ‘yes’ or ‘no objection’, the surviving relatives can indicate during the conversation that the registration does not reflect the patient's wishes as they understood them. For example, the patient may have recently expressed a different wish to their relatives. Additionally, it is possible that the patient did not receive the letters regarding the registration or was unable to understand their content. As a result, they may not have been aware that they were registered as ‘no objection’.

Are the surviving relatives convinced that the ‘yes’ or ‘no objection’ registration is incorrect? If so, they can make this known and explain it to the official. There is no set format for how they do this. The law speaks of “making it plausible,” without further defining what that entails. It is not about ‘proving’ it, but about ‘setting out’ and ‘explaining’ it. The official asks the surviving relatives to explain why they believe the registration does not correspond with the patient’s wishes. If they can explain this convincingly enough, the registration can be rendered invalid, and the information provided by the relatives will apply. It is up to the professional judgment of the official to decide whether they can trust that the registration corresponds with the patient’s wishes.

Please note:

• If a patient is registered as ‘No, I do not give consent’, the next of kin cannot change this. In that case, no donation will take place.
• Has the patient excluded certain organs or tissues from donation? Then the next of kin cannot change this either. In that case, no donation of the relevant organs or tissues takes place.

When the official conducts the conversation with the next of kin about donation, their approach is always to realize the patient's wishes. In the case of a registration of ‘yes’ or ‘no objection’, this means that the official's starting point is to ensure the donation takes place. It may be that the next of kin object to the donation itself. This is a different type of objection than an objection to the nature of the registration (see 4.10). In this case, the following procedure applies.

The next of kin may indicate during the donation conversation that they personally have difficulty with the donation. If this happens, the official tries to determine what can help the next of kin to accommodate their values and needs. In doing so, they look at whether philosophical or religious views might play a role and discuss this. The official may point out that the next of kin are not being asked to give consent (in the case of a ‘yes’ or ‘no objection’ registration); the patient has already done that themselves. However, the official must explain how this registration was established (see 3.2.2 and 3.2.3).

In a conversation where personal objections from the next of kin arise, it is extra important to engage in a dialogue with them and identify the background of these objections. Sometimes, for example, they do not have a general objection to donation, but have reservations about certain organs or tissues.

Below are some factors that may play a role in the next of kin's objection. The official will address these in the dialogue.

Is there consent for donation? Then this consent must be recorded in the donor's medical file and on the donation form. Below is who is responsible for what. If possible, also describe the consent process.

• Medical file: by the physician
• Donation form/death certificates: by the physician
• Nursing file: by the nurse
• DPA, ODC file (for organ donation): by the ODC

In case of unnatural death:

• Death certificates: by the forensic physician. (NOTE: the donation form must be completed by the involved hospital physician.)

Is there consent from the patient and have the next of kin been informed? Or have you – if necessary – requested consent from the surviving relatives or a designated person?

And is there – in the case of an unnatural death – also consent from the public prosecutor? Then the donation procedure can be started.

In the case of organ donation, the next step depends on the type of procedure. See chapter 5 for the DBD procedure and chapter 6 for the DCD procedure. Always call the on-duty ODC. This can be done via the Organ Center (071 579 57 95).

In the case of tissue donation, register the potential tissue donor with the Organ Center (071 579 57 95). Also see: Part 2: Tissue donation.

This chapter describes the DBD procedure. The DBD procedure starts after the conversation with the family about donation has taken place. Subsequently, death is determined, donor management begins, the required examinations are performed, and the donor is registered.

The examinations and registration are described in Chapter 7. Diagram 5 describes at which step of the donation process this takes place.

After contraindications for donation have been ruled out and donation has been discussed with the family, it is determined which procedure will be started: DBD or DCD. If brain death is suspected, the DBD procedure is started. The first step is the determination of brain death. Contact the on-duty ODC for the determination of brain death.

The brain death protocol is used for the determination of brain death. This protocol has been established by Order in Council. The Brain death protocol must therefore be followed to determine brain death. The most recent protocol has been in effect since June 1, 2017.

In the Brain Death Protocol, the ‘whole brain death’ concept is the starting point. According to this concept, brain death occurs when all functions of the brain, including the brainstem and the medulla oblongata, are completely and irreversibly lost. To be able to determine brain death, the following conditions must be met (summarized):

1. It has been established that the so-called preliminary conditions have been met:

• The cause of the brain injury is known.
• The brain injury is fatal and untreatable.
• No potentially reversible causes for the dysfunction can be identified, such as hypothermia, intoxication, hypotension, blockade of the neuromuscular junction, or a severe biochemical or metabolic disorder. Resuscitation within the past 12 hours may also result in dysfunction.

2. Pharmacological neurodepression has been ruled out.

3. A clinical neurological examination has been performed.

4. Additional examinations have been performed, such as electroencephalography (EEG), transcranial Doppler (TCD), or CT angiography of the cerebral vessels (CTA).

5. An apnea test has been performed.

Apnea test during ECMO treatment

In the advice of theHealth Council of the Netherlands ‘Determining death in post-mortem organ donation’The execution of the apnea test in patients treated with ECMO is not addressed. This is because, at the time that advice was written, there was insufficient clarity on the matter. Consequently, it is not included in the brain death protocol. By temporarily adjusting the ECMO settings, it is often still possible to perform an apnea test on patients on ECMO.

Through the following adjustments to the technical criteria for performing the apnea test, as described in section G3.5 of the Health Council report, this test is often feasible in patients on ECMO (David M. Greer, JAMA 2020 - Supplement 7).

During preparation:

• In addition to 10 minutes of ventilation with 100% oxygen, also administer 100% oxygen via the ECMO circuit.
• Maintain the ECMO circuit blood flow and reduce the gas flow across the oxygenator until a PaCO2 of at least 40 mmHg (5.3 kPa) is reached, or a PaCO2 of at least 45 mmHg (6 kPa) in patients with chronic lung disease.

During the test:

• Maintain the blood flow of the ECMO circuit and turn the gas flow over the oxygenator back to 0.5-1 L/minute with 100% oxygen.
• In cases of peripherally cannulated VA-ECMO, simultaneously determine the PaCO2 from the right arm and from the ECMO circuit post-oxygenator to ensure certainty regarding the PaCO2 of the blood flowing toward the head.

Interpretation

The apnea test can be terminated upon reaching a PaCO2 of 50 mmHg (6.65 kPa) or higher (or 60 mmHg, i.e., 8 kPa, in individuals with chronic lung disease) in both blood gas analyses without the occurrence of respiratory movements.

If brain death has been determined based on these steps and there is consent for donation, please fill out the brain death form.

Diagnostics in children younger than 1 year

To determine brain death in children younger than 1 year, it is necessary to repeat the aforementioned tests after an observation period. See the Brain Death Protocol Decision. The child's age determines the length of the observation period.

The required observation period is:

• For children in the neonatal period (first week of life): 48 hours.
• For children thereafter up to the age of 2 months: 24 hours.
• For children aged 2 to 12 months: 12 hours.

Brain death cannot be determined: what now?

It is possible that during the execution of the Brain Death Protocol, a test shows that brain death cannot (yet) be determined. In that case, there are 2 possibilities:

1. Repeat the test after a certain period of time.
2. Switch to the DCD procedure.

The decision regarding this is made in consultation with the neurologist, the intensivist, and the patient's family. The preference is always for a DBD procedure, as more organs can be donated and this generally leads to better transplant outcomes.

After brain death has been determined, the ODC starts the organization and coordination of the organ donation procedure. These activities include, among other things, registering the donor with Eurotransplant and organizing the logistics. See for this chapter 7.

Until the moment of organ retrieval, it is important to maintain or improve organ function as much as possible. This is called 'donor management'. This section provides recommendations for this. These recommendations apply from the moment it is decided to terminate life-sustaining treatment until the moment of organ retrieval.

The recommendations in this section are guidelines: they are not intended to be followed rigidly if the patient's situation requires something else. It is advised to choose the treatments from the guideline with which you are most familiar. Donor management is largely similar to the treatment of ICU patients.

There are some specific points of attention, which are described in this section. The attending physician remains responsible for the patient's treatment.

5.3.1. Hemodynamic (in)stability: monitoring

In patients who become brain dead, hemodynamic changes occur. Hemodynamic monitoring is therefore necessary. The goal is to monitor good organ perfusion.

First, a compensatory systemic hypertension occurs due to increasing intracranial pressure, possibly associated with bradycardia. Subsequently, a catecholamine storm can occur, in which strong sympathetic activation takes place due to catecholamine release, resulting in strong vasoconstriction with increased vascular resistance and tachycardia.

After the catecholamine storm, there is a loss of sympathetic activation, causing peripheral vasodilation. This results in hypotension and, if untreated, can lead to hypoperfusion. Moreover, pulmonary edema can occur during the catecholamine storm.

Furthermore, various endocrine changes often occur due to the loss of pituitary function. In particular, the posterior pituitary gland is often affected to such an extent that diabetes insipidus occurs, with associated changes in intravascular volume status and electrolyte changes. Profuse diuresis does not always have to be the result of diabetes insipidus. This can also be the result of large fluid administration and in that case does not require treatment. In addition, the insulin concentration can decrease and insulin resistance can develop, where it is not uncommon for hyperglycemia to occur. Furthermore, the function of the hypothalamus may be reduced or altered, which can lead to a loss of body temperature control.

Moreover, an inflammatory reaction often occurs because inflammatory mediators are released by the damaged brain. Finally, coagulation problems frequently occur in patients with brain injuries.

Hemodynamic monitoring does not differ from that of normal ICU patients.

In this regard, the practitioner must be alert to the possible occurrence of hemodynamic changes and hemodynamic instability, which must be treated quickly and adequately. The minimum monitoring advised consists of: electrocardiography (ECG), invasive blood pressure measurement, and monitoring of diuresis. In addition, the placement of a central venous catheter, possibly with monitoring of central venous pressure, can be considered with a low threshold. This is given the chance of or the presence of hemodynamic instability. In case of difficult hemodynamic control or deterioration, monitoring can be intensified with other locally available monitoring methods with which one has experience and expertise. This includes echocardiography, PiCCO, or a Swan-Ganz catheter.

According to current consensus, there is adequate volume administration, with a low necessary dosage of vasoactive agents, if there is:

• Mean arterial pressure (MAP) 60 – 90 mmHg
• Diuresis > 0.5 – 3 mL/kg/hour
• Heart rate 60 – 120/min

5.3.2. Fluid therapy

In hemodynamically unstable donors, fluid resuscitation is the treatment of first choice and often necessary. Due to loss of intravascular volume, volume administration is needed to maintain organ perfusion without inducing hypervolemia.

Both crystalloids and colloids, with the exception of synthetic colloids, can be used for this.

A presumed challenge in fluid therapy concerns the conflicting goals for kidney and lung donation. Recently, however, it has been shown that a lower central venous pressure does not lead to delayed function or reduced survival of the kidney graft. A lower central venous pressure does have a protective effect on the heart and lungs. Strict values for central venous pressure are not included in this protocol. However, overfilling must be avoided and a euvolemic fluid balance should be pursued.

It is often chosen to fill the donor with isotonic crystalloid solutions. If frequent administration of crystalloid solutions is necessary, switching to non-synthetic colloid solutions may be considered. In practice, however, colloid solutions are rarely or never used in the intensive care unit anymore. Administering colloids may reduce the total required volume. This potentially reduces the risk of pulmonary edema.

Recommendations for fluid therapy

• Aim for euvolemia in the donor.
• Preferably choose fluid therapy with bolus administration instead of continuous administration to prevent the risk of hypervolemia.

5.3.3. Hemodynamic support

If fluid therapy is insufficient to achieve hemodynamic goals, it is advised to administer a vasopressor and/or inotrope. Various agents can be used for this purpose.

In many ICUs, norepinephrine is the most commonly used agent. Norepinephrine has an alpha-agonist effect that increases peripheral vascular resistance, resulting in an increase in blood pressure. Furthermore, it also has a beta-1-agonist effect, which leads to an increase in heart rate and cardiac output. Norepinephrine can be combined with other vasoactive medications, such as dobutamine, milrinone, or enoximone. The goal should be to use the lowest possible dosage of norepinephrine. Higher dosages are associated with a greater risk of cardiac dysfunction after transplantation and higher recipient mortality.

Another agent that can be used is dopamine. In practice, however, this is rarely administered.

If higher dosages of catecholamines are required, vasopressin can also be administered. This has a protective effect on cardiac function and may lead to more organs remaining available for transplantation. Start vasopressin administration at a low dose and titrate up to a maximum dose of 40 mU/kg/hour. As an alternative to vasopressin, terlipressin (1 mg IV bolus) can be given.

An adverse effect of vasoactive agents that have an agonist effect on alpha-receptors is an increase in pulmonary capillary permeability. This can lead to pulmonary edema. In addition, stimulation of alpha-receptors may lead to vasoconstriction of the coronary and mesenteric arteries. Avoid high dosages of beta-agonists in potential heart donors to prevent, among other things, downregulation of beta-receptors. Furthermore, consider using additional positive inotropic agents in a timely manner, such as a phosphodiesterase inhibitor.

Recommendations for hemodynamic support

• Start vasopressors and/or inotropes according to the local protocol if hemodynamic goals cannot be met with fluid administration.
• Avoid high dosages of beta-agonists in potential heart donors.

5.3.4. Arrhythmias

Arrhythmias occur regularly in brain-dead patients. Sinus tachycardia is the most common arrhythmia, followed by sinus bradycardia and atrial fibrillation. Arrhythmias can be treated according to standard guidelines, but only if medications with shorter half-lives are used.

Tachycardia

Tachycardia often occurs as a result of the increased catecholamine concentration at the onset of brain death or as a result of hypovolemia. If the tachycardia leads to hypotension and is therefore poorly tolerated by the heart, congestive heart failure may develop.

Recommendations for the treatment of tachycardia

• Rule out reversible underlying causes of the tachycardia before starting pharmacological treatment. An underlying cause can be, for example, hypovolemia.
• A poorly tolerated tachycardia should be treated with a beta-blocker. Esmolol is preferred due to its short half-life.
• Preferably choose intravenous administration via a syringe pump.

Bradycardia

In the case of increased intracranial pressure, a Cushing response may occur. This can involve bradycardia (sinus bradycardia or nodal escape rhythm), in addition to hypertension and a potentially abnormal breathing pattern. Increased intracranial pressure can also lead to compression of the brain nuclei from which the vagus nerve originates. As a result, atropine is no longer effective.

Recommendations for the treatment of bradycardia

• Preferably administer isoprenaline, due to its direct chronotropic effect on the heart muscle.
• Administer isoprenaline in a dosage of 1 mcg intravenously. Repeat this every minute until the heart rate increases. Alternatively, continue treatment with a continuous infusion titrated to the heart rate.
• In case of acute emergency, administer adrenaline.
• If chronotropic medication proves insufficiently effective, consider intravascular pacing.

Atrial fibrillation

Atrial fibrillation may be pre-existent, but can also occur due to cardiac stressors after or during the onset of brain death. Additionally, it can be triggered by hypovolemia or electrolyte disturbances (such as hypokalemia and hypomagnesemia).

Recommendations for atrial fibrillation

• If possible, correct potential underlying causes of atrial fibrillation.
• Consider magnesium supplementation.
• Attempt cardioversion – chemical or electrical – to convert the heart rhythm to a sinus rhythm. Heart donation is then theoretically still possible.

5.3.5. Hypertension

In the treatment of hypertension, a distinction must be made between pre-existent hypertension and new hypertension, which is the result of catecholamine release or increased intracranial pressure.

Newly developed, acute hypertension must be treated as quickly as possible to prevent myocardial damage and pulmonary edema. With systolic blood pressures above 200 mmHg or a mean arterial pressure (MAP) above 130 mmHg, there is an increased risk of cardiac damage, resulting in circulatory arrest. A catecholamine storm is defined as a systolic blood pressure of 200 mmHg for at least 10 minutes and a tachycardia of more than 140 beats per minute, without any other identifiable cause. If treated immediately, there is still a good chance of a successful heart transplant.

Hypertension should be treated according to the local protocol, using antihypertensive medication with which the intensivist has experience. In the case of heart donation, labetalol should be avoided due to its long half-life.

Recommendations for the treatment of hypertension

• Start antihypertensive treatment if systolic blood pressure > 200 mmHg or MAP > 130 mmHg.
• Preferably use a beta-blocker (metoprolol, esmolol, or labetalol) or nitroprusside, nitroglycerin, or nicardipine. For DCD heart donation, a beta-blocker is the second choice after a calcium antagonist.
• For potential heart donors, preferably do not use beta-blockers, but rather one of the alternatives.

5.3.6. Ventilation

Lung damage occurs in 30% of patients with neurological injury. For potential lung donors, follow the same treatment strategy as for patients with lung injury in the intensive care unit. Ventilation is aimed at lung-protective ventilation settings.

Current protective ventilation guidelines advise ventilating with a tidal volume of 6-8 ml/ideal body weight (in kg). In addition, PEEP should be optimized if possible, with a target PEEP of 8 – 10 cmH2O. It is also recommended to perform a recruitment maneuver after the apnea test.

If lung donation is not possible, maintain the settings that achieve good saturation and do not change the ventilation settings too much. If there is room, PEEP can be lowered to reduce the impact of ventilation on hemodynamics.

Recommendations for ventilation in potential lung donation

• Ventilate the lungs protectively according to current lung-protective guidelines.
• Perform a recruitment maneuver after the apnea test.
• Consider recruitment maneuvers to improve the PaO2/FiO2 ratio.
• Improve lung quality through bronchial toilet or suctioning via bronchoscopy.
• Use a restrictive fluid policy.
• Prevent sputum stasis and suction the tube regularly.
• Insert a nasogastric tube with suction to prevent aspiration.
• Raise the head of the bed to 30 degrees for proper donor positioning.
• Follow local guidelines for the prevention of ventilator-associated pneumonia.

5.3.7. Use of medication

Corticosteroids

Little is known about the prevalence of corticosteroid deficiency in brain-dead patients. There are indications of an increased risk of relative corticosteroid deficiency, but the clinical consequences of this are unclear. Research shows that intravenous administration of methylprednisolone has a protective effect against ischemia/reperfusion injury. As a result, acute rejection occurs less frequently. It also improves oxygenation.

Recommendations for the use of corticosteroids

• Administer 15mg/kg methylprednisolone intravenously after brain death has been established. This has positive effects on organ function after transplantation. Repeat this every 24 hours.

Vasopressin analogues

In brain-dead patients, damage to the pituitary gland often occurs. If damage occurs to the posterior lobe of the pituitary gland (neurohypophysis), diabetes insipidus can develop because no or less antidiuretic hormone is released. Diabetes insipidus occurs in 80% of DBD donors. Signs of this are polyuria (diuresis > 4 ml/kg/hour) and hypernatremia (> 145 mmol/l), an increase in serum osmolality (≥ 300 mosm/l), and a decrease in urine osmolality (≤ 200 mosmol/kg).

Other possible causes of diabetes insipidus must be excluded. This includes osmotic diuresis as a result of hyperglycemia or high diuresis due to the administration of mannitol or other diuretics. High diuresis can also be the result of large fluid administration and in that case does not require treatment with desmopressin. Sometimes, in the case of high diuresis, it is necessary to replenish volume and aim for euvolemia.

Recommendations for the use of vasopressin analogues

• Use desmopressin (DDAVP) 1 – 4 mcg IV in case of (suspected) diabetes insipidus. In case of persistent polyuria (> 3 ml/kg/hour), another 1 – 2 mcg of desmopressin IV can be administered. This can be repeated every 6 hours.
• Vasopressin and terlipressin have less effect in the treatment of diabetes insipidus. These agents can play a role in the treatment of hemodynamic instability.

Thyroid hormone

In the majority of brain-dead patients, the concentrations of TSH (thyroid-stimulating hormone), T3, and T4 are below the normal range. In those cases, it is often a matter of 'sick euthyroid syndrome' and not an actual TSH deficiency. These patients often do not require thyroid hormone supplementation. In the most recent literature, it is advised against administering thyroid hormones as standard (Dhar NEJM, 2023).

Recommendations for the administration of thyroid hormones

• Do not administer thyroid hormones as standard.
• Consider the use of thyroid hormones if hemodynamic instability persists, despite euvolemia and optimal dosages of vasoactive medication support. Thyroid hormones increase the contractility of the heart. This is due to their chronotropic effect and a reduction in systemic vascular resistance.

5.3.8. Combined hormonal therapy

It is advised against supplementing vasopressin, corticosteroids, and thyroid hormone as standard. As previously described, it is recommended to start methylprednisolone in every organ donor as early as possible after brain death. In addition, the advice is to reserve vasopressin and thyroid hormone for patients who remain hemodynamically unstable despite optimal therapy.

Recommendations for applying combined hormone therapy

• Do not choose combined hormone therapy as standard.

5.3.9. Glucose regulation

Hyperglycemia is common in brain-dead patients and is likely a consequence of high concentrations of catecholamines and the administration of corticosteroids. There is little research known about the effect of glucose control in organ donors.

Recommendations for glucose regulation

• Follow current practice: aim for a serum glucose value of 6 – 8 mmol/l.

5.3.10. Electrolytes

Electrolyte disturbances can occur in DBD donors. Therefore, special attention is required for hypernatremia resulting from diabetes insipidus (see 5.3.7).

It is recommended to treat electrolyte disturbances according to the electrolyte disturbances guideline, which advises aiming for normal values. Electrolyte disturbances are not a contraindication for transplantation.

Recommendations for the treatment of electrolyte disturbances

• Aim for normal electrolyte values.
• Follow the electrolyte disturbances guideline for the treatment of electrolyte disturbances.

5.3.11. Transfusion thresholds

There is no known literature on the influence of red blood cell transfusion on the short-term preservation of donor organs. Therefore, follow current practice, in which a hemoglobin level down to 4.3 mmol/L is accepted. If the value is lower than 4.3, it is advised to transfuse red blood cells. This advice is based on large randomized controlled trials in critically ill patients, where no difference in survival was seen with a high threshold (Hb 6 mmol/L) compared to a low threshold. There is no literature on platelet concentrations or coagulation times in organ donors.

Recommendations for transfusion thresholds

• Follow current practice: Hb > 4.3 mmol/L.
• In case of clinical bleeding, administer platelets and/or plasma factors.
• Consult with the accepting physician before applying perioperative correction of coagulation factors.

5.3.12. Temperature regulation

Loss of temperature regulation can occur in brain-dead patients. This can potentially lead to hypothermia. Hypothermia is known to lead to various problems. For example, coagulation disorders and arrhythmias can occur. Cooling to 34 °C is discouraged (Patel JAMA, 2024). Consider passive cooling in case of fever.

Recommendations for temperature regulation

• Maintain the donor's temperature > 35 °C.
• Consider passive cooling in case of fever.

5.3.13. Nutrition

Brain-dead patients should receive enteral nutrition according to the local protocol (CherciClin transplant, 2023 (37)).

Recommendations for nutrition

• Start or continue enteral nutrition according to the local protocol.

5.3.14. Prevention and treatment of bacterial infections

During ICU admission, the prophylactic administration of antibiotics in potential organ donors is discouraged. An exception applies to the administration of SDD, which is part of standard ICU treatment.

Antibiotic treatment of existing infections must be continued or started according to the local or national protocol. This also applies to new infections confirmed by microbiological diagnostics. These (existing and new) infections are not always a contraindication for organ donation. If an infection is present, a decision regarding the suitability of the organs for transplantation must be made in consultation with the transplant physicians.

Recommendations for the prevention and treatment of infections

• Collect blood, sputum, urine, and, if applicable, wound cultures from all donors. Repeat this after 24 hours if necessary in case of fever.
• Continue antibiotic treatments that have already been started.
• Treat proven infections according to the local or national protocol.
• Administer SDD/SOD according to the protocol.

The deceased is brought to the operating room at the time previously agreed upon with all involved parties, including the family. This is a few hours after the determination of brain death.

Forms

The following forms must be sent from the ICU to the OR:

• The brain death form.
• The donation form completed by the physician.

This chapter describes the DCD procedure. It addresses the withdrawal of treatment, the agonal phase, and the determination of death based on circulatory criteria. Figure 6 shows which step of the donation process this chapter covers.

The DCD procedure starts when it has been decided to withdraw life-sustaining treatment from a patient and when brain death cannot be determined. DCD specifically concerns a situation in which – based on a careful prognosis – the death of the patient is expected and the moment of death can be foreseen within certain time limits. If the family has given consent for donation, the ODC is called. This can be done directly or via the Organ Center (071 579 57 95).

It takes a number of hours before the patient's treatment is actually stopped. During this period, actions are taken in accordance with the NVIC guidelines for providing end-of-life care. Providing comfort is an essential part of this.

In addition, for a potential donor, it is important to (continue to) ensure good organ function. This means that it may be necessary to perform medical procedures.

These procedures are not in the patient's interest, but are performed for the benefit of organ donation. The intensivist remains the attending physician and is responsible for this. The ODC can support and advise the intensivist.

6.1.1 Points of attention for DCD heart donation

• Be cautious with the administration of inotropes, vasopressors, and other cardiodepressive agents. If necessary, preferably use short-acting agents and try to dose them as low as possible.
• For the heart perfusion machine to function, the donor's hematocrit should ideally be > 0.3 l/l.

6.1.2 Points of attention for heparin administration in DCD donation

• This concerns the administration of heparin for the benefit of liver, lung, kidney, and pancreas quality.
• Heparin is administered at the time of switch-off.
• It is advised not to administer heparin to trauma patients with clear external injuries.
• In the case of a retrieval procedure with normothermic regional perfusion (NRP), the heparin does not need to be administered in the ICU. This is done during the perfusion procedure in the OR.
• In the case of organ donation after euthanasia, heparin is also administered. See guideline for organ donation after euthanasia.

6.1.3 Points of attention for abdominal normothermic regional perfusion (aNRP)

aNRP is an in-situ perfusion technique that can be used for DCD donors; this takes place in the OR. After 1-2 hours of aNRP, organ retrieval takes place according to the standard protocol. If indicated, liver function can be tested during aNRP.

• The ODCs order the necessary erythrocyte concentrates (packed cells) in a timely manner.
• For the aNRP to function, the donor's hematocrit must be > 0.3 l/l.

Between the decision to stop treatment and the actual stopping of treatment, the ODC coordinates the donation procedure. For example, the ODC ensures that examinations are carried out to map the quality of the organs, registers the donor with Eurotransplant, and coordinates the logistics. These activities are described in Chapter 7.

It may occur that during the period leading up to the withdrawal of treatment, signs indicating brain death appear. There are then 2 possibilities:

1. Continue the DCD procedure.
2. Stop the DCD procedure and start the Brain Death Protocol, in order to subsequently switch to the DBD procedure.

The decision regarding this is made in consultation with the neurologist, the intensivist, and the family. If they decide to carry out the Brain Death Protocol and the donor was already registered with Eurotransplant, the donor must be re-registered after brain death has been established. This is because the allocation must then be restarted.

The preference is always for a DBD procedure, because more organs can be donated and this generally leads to better transplant results.

The time at which life-sustaining treatment is stopped (the switch-off) is coordinated with the family, the intensive care unit, the ODC, and the independent retrieval team.

The withdrawal of treatment almost always takes place in the ICU. After death, there is no circulation. This causes ischemic damage to the organs. The time between death and the start of perfusion in the operating room (warm ischemia time) must therefore be as short as possible. After death, the donor is quickly transported to the OR, where the retrieval team is ready.

The switch-off can also take place in the OR. The advantage of this is that the warm ischemia time is shorter. The decision regarding this must always be made in close consultation with the family. They must provide consent for this.

The intensivist remains responsible for the treatment and declares death.

The period between the switch-off and the patient's death is called the agonal phase. At the moment of switch-off or immediately thereafter, IV heparin 300 IU/kg of body weight is administered. This must be done while circulation is still present in the patient. During the agonal phase, the perfusion and oxygenation of the organs are observed. The ODC documents the heart rate, blood pressure, respiration, and oxygen saturation.

Duration of the agonal phase

There is considerable variation in the duration of the agonal phase: sometimes circulatory arrest occurs after a few minutes, sometimes after several hours or days. For the quality of the organs, the agonal phase should not last longer than 1 to 2 hours.

After this period, an organ will be less suitable or even unsuitable for transplantation. Exactly how long that period may be depends on the course of the agonal phase and the organs being donated.

Table 2 indicates the maximum duration until circulatory arrest.

Table 2: Agonal phase: Maximum duration until circulatory arrest

These limits may be deviated from in consultation with the accepting physician.

In a DCD procedure, death is determined based on circulatory criteria. The procedure for this is described in the Health Council advisory report. The procedure has 2 crucial moments:

1. It has been established that there is a circulatory arrest.
   1. There must be no doubt whatsoever that the blood circulation has stopped. To prevent such doubt, it is recommended to use a fixed arterial line that can measure all changes in arterial pulsations and pressure with sufficient sensitivity and specificity. In addition, non-invasive examinations can be performed if necessary, such as non-invasive blood pressure measurement, heart auscultation, electrocardiography, or echocardiography.
   2. To determine death, the absence of blood flow is therefore the decisive criterion.
2. After the determination of circulatory arrest, an observation period is incorporated without medical intervention: the 5-minute no-touch period.
   1. The no-touch period is an observation period during which no actions may be performed on the patient. This observation period begins the moment it is determined that the blood circulation has stopped. The period ends the moment it is sufficiently certain that the circulatory arrest is permanent. This no-touch period has been set at 5 minutes in the Netherlands. A condition is that no further interventions take place that could unintentionally lead to the restoration of cerebral circulation.
   2. Only after the 5-minute no-touch period can death be definitively determined. During the 5-minute no-touch period, the donor may not be transported.

The deceased is brought to the operating room immediately after the determination of death. The time between circulatory arrest and the start of perfusion must be as short as possible to maintain the quality of the organs.

Form

The donation form containing the time of death (filled out by the physician) must be sent from the ICU to the OR.

This chapter describes the organization surrounding the donation procedure. The ODC coordinates this procedure. The chapter covers the examinations performed, the heteroanamnesis, the registration of the donor with Eurotransplant, and the logistics. These steps are part of both the DBD and DCD procedures. This is illustrated in Diagram 7.

For a potential donor, a number of examinations are performed to assess which organs are suitable for donation. Blood is always drawn for tissue typing and virology. The ODC handles the logistics of this typing and the various examinations. Which examinations these are is listed in Table 3. Receiving centers may request additional examinations.

Note: For every potential donor, the examinations listed under 'General/Kidneys' must be performed. For the donation of other organs, the remaining examinations are added to these.

Table 3: Medical examinations to be performed on a potential donor

In addition to the examinations mentioned in 7.1, it is important to obtain a complete picture of the medical and social history of the (potential) donor and their current situation. Consider:

• Age, gender, and occupation.
• (Measured) height and weight.
• Indication for admission.
• Chronic conditions, such as hypertension and diabetes mellitus.
• Medical history.
• Cause of death.
• Intoxications (number of pack-years of nicotine, use of alcohol and drugs).
• Home medication use.
• Risk behavior regarding sexually transmitted diseases, such as HIV.
• Surgeries undergone.
• Allergies.
• Travel history in the past year: where and when a donor has been abroad in the year prior to death (both within and outside Europe).
• The clinical course during admission.

The ODC obtains this information by reviewing the medical record and by speaking with the family, the intensivist, and/or the general practitioner of the potential donor.

After all necessary information has been collected and the patient has been found suitable as a donor, the ODC registers the patient with Eurotransplant. Eurotransplant allocates organs to recipients according to Dutch allocation rules.

As coordinator of the donation procedure, the ODC organizes the logistics surrounding the procedure. There must be 4 to 6 hours between the time of donor registration and the start of organ retrieval; if heart donation takes place, this is 8 hours.

This time is needed to call in the recipients and perform preparations for the transplantation. The exact number of hours required depends on the organs being donated.

The ODC arranges the logistics:

• An operating room is available.
• The retrieval team is called in.
• Cross-match material is sent to the laboratory.
• Transport of the organs is arranged.

This chapter provides guidelines for the ODC to inform family members about the donation procedure and to support them during the process. In Figure 8, you can see that providing information and care for the family is a process that runs throughout the entire procedure.

Before the ODC speaks with the donor's family, they coordinate the topics to be discussed with the physician. The physician may have already discussed some topics during the donation conversation. The physician can indicate whether it is useful to repeat and further explain this information.

It is important to respond to the family's need for information. This is left to the professional judgment of the ODC. It is recommended to involve the attending physician or nurse in the conversations with the family.

Topics for the conversation include:

• The duration of the entire procedure (never provide an exact duration, as this is difficult to estimate).
• The required examinations to determine the suitability of the organs, including any inquiries with the patient's GP or other healthcare providers.
• Possibilities for the family to be present in the ICU.
• Possibilities for the family to say goodbye to the patient and, if desired, perform specific rituals.
• The time of death in DBD and DCD.
• The donation procedure and the way it is carried out: with care, respect, and within legal standards.
• The patient's medical and social history (inquire about this with the family).
• Which organs and tissues can be donated.
• The required removal of associated structures to make transplantation possible (e.g., spleen, blood vessels, and intestine).
• The possibility that organs are tested before being transplanted into the recipient.
• The appearance of the deceased after donation: incisions and (pale) appearance.
• The (objective) allocation system used by Eurotransplant for assigning organs to the recipient(s) (indicate that there is an exchange system with other countries).
• Consent for research on organs that are rejected (see 8.2).
• The possibility that donated organs may ultimately prove unsuitable for transplantation.
• The fact that organ donation is always anonymous.

In addition, the ODC assesses the family's needs regarding the aftercare process (see 8.4 and 8.5), and answers any questions. Arrangements are also made regarding how the family wishes to be kept informed about the operation.

Finally, always provide the NTS leaflet 'Organ donation, information for family', so that family members can read the information about the procedure at their leisure.

In a combined organ and tissue donation procedure, the ODC also arranges the procedure regarding tissue donation. This is done in accordance with the description in Part 2: Tissue donation. If necessary, the ODC transfers the tasks regarding tissue donation to the physician.

During the conversation with the family, the ODC discusses whether there is consent for the removal of organs that are not used for transplantation. This can involve 2 situations:

An organ that has already been removed is subsequently rejected for transplantation. This may involve a contraindication or issues related to the recipient.

One or more organs are removed solely for research. In addition, the donor also donates other organs.

If the patient has given consent for donation in the Donor Register without excluding transplantation-related research, the ODC does not need to ask the family for consent for the first situation. The family must be informed of the fact that the patient did not object to the use of the organ for transplantation-related research.

In all other cases, and if some organs are only removed for research, the family must provide specific, written consent. Consent forms are available for this purpose.

All information provided to the family must be recorded in the following files:

• Medical file:: by the physician
• Donation form/death certificates: by the physician
• Nursing file: by the nurse
• DPA, ODC file: by the ODC

In case of unnatural death:

• Death papers: by the forensic physician.
• Note: the donation form must be completed by the attending hospital physician.

During the procedure, the ODC asks the family about their need for aftercare. If the family wishes, the ODC will contact the family 6 weeks after the death. They can then provide feedback on the transplant results:

• Was the organ transplanted?
• What is the gender and age category of the recipient?
• Is the organ still functioning?
• In the case of a combined organ and tissue procedure: were the retrieved tissues found suitable for transplantation? And if known: did the transplantation take place?

Experience shows that the vast majority of surviving relatives greatly appreciate this feedback and that it can support them in the grieving process.

There are various forms of aftercare available for surviving relatives. The ODC brings these up during the conversation with the family (before or after the procedure):

• Did the patient spend a shorter or longer period in the intensive care unit? If so, the family can have a follow-up conversation with the staff of that department.
• Twice a year, an information bulletin is published by and for the surviving relatives of organ and tissue donors. This bulletin is called: ‘Nabestaanden Contact’ (Surviving Relatives Contact). It can be ordered viainfo@transplantatiestichting.nl.
• If surviving relatives want to know more about the impact of a transplant on the life of the recipient, the book ‘Hoe kan ik je ooit bedanken?’ (How can I ever thank you?) is recommended. This book contains various thank-you letters from recipients. It can be ordered viainfo@transplantatiestichting.nl.
• It frequently happens that the recipient of an organ or tissue wishes to thank the donor's surviving relatives by letter. This is sent to the surviving relatives via the ODC. The ODC checks this letter for traceability. Subsequently, the ODC contacts the donor's family to ask if they wish to receive this letter.