Establishing standards for controlled donation after circulatory determination of death in adults: the Bucharest international European Society for Organ Transplantation consensus

Abstract

Controlled donation after circulatory determination of death (cDCDD) is increasingly vital to expanding deceased organ donation globally, yet variability exists in clinical, legal, and ethical practices. This study utilized a Delphi consensus process involving 37 international experts to develop recommendations to guide the development and operation of adult cDCDD programs. Two survey rounds evaluated agreement on system requirements, donor identification, medical suitability, communication, end-of-life care, and ante-mortem interventions. Consensus was achieved on numerous recommendations emphasizing the need for robust legal frameworks distinct from end-of-life care decisions, multidisciplinary approaches for donor suitability assessment, and clear, sensitive communication led by trained donation professionals. Ensuring patient comfort and dignity during withdrawal of life-sustaining measures, alongside optimizing donation outcomes, was prioritized. Use of ante-mortem interventions was deemed to require careful balancing of benefits and burdens in line with patient and family preferences. The findings highlight international variability and underscore the importance of tailored protocols, education, and further research to establish an evidence base for ante-mortem interventions and improve clinical prediction of donation feasibility. These consensus recommendations aim to advance ethical, effective, and sustainable adult cDCDD programs worldwide.

Graphical Abstract

Introduction

Controlled donation after circulatory determination of death (cDCDD) has emerged as a critical means for expanding deceased organ donation worldwide [1, 2]. Recent data reveal that cDCDD provides a significant contribution to the organ donation rates across various countries, helping to meet the rising demand for transplantation [3]. When appropriately integrated into end-of-life care planning, cDCDD broadens opportunities allowing the donation choices of patients and their families to be considered and respected. Despite its growing role, cDCDD programs face distinct ethical, clinical, and logistical challenges that set them apart from donation after neurological determination of death (DNDD). These challenges include complex decision-making processes surrounding the withdrawal of life-sustaining measures (WLSM), the process of death determination, the management of warm ischemic injury, as well as the integration of ante-mortem interventions to optimize transplant outcomes [4].

This paper presents consensus recommendations developed through a Delphi process involving international experts in adult deceased donation. The aim is to provide ethical, clinical, and operational guidance for establishing and sustaining adult cDCDD programs, considering the variability in legal frameworks, healthcare infrastructure, and cultural contexts. Emphasis is placed on maintaining integrity of end-of-life care, ensuring informed and sensitive communication with patients and families, optimizing donor identification and assessment, and balancing patient-centered care with the imperative to maximize donation opportunities. This work seeks to support national programs in delivering effective, ethical, and sustainable cDCDD pathways within the broader deceased donation landscape.

Materials and methods

The work described in this paper formed part of the European Society for Organ Transplantation (ESOT) Donation after Circulatory Determination of Death (DCDD) Consensus Project, a multi-phase initiative designed to establish standardized terminology and recommendations in controlled DCDD practice. The Delphi process applied in the overarching DCDD Consensus project is outlined in detail elsewhere [5]. This paper is the result of one of four subcommittees, with this group tasked with developing consensus on best practice standards and recommendations for adult DCDD.

A steering committee comprised of 9 members with expertise in adult deceased donation developed a questionnaire addressing a range of topics identified as priorities via literature review and group discussions. The committee identified expert panellists according to the criteria described in Martin et al. [5], who were invited to participate in the Delphi process. The two coordinators were excluded from the expert panel.

Two survey waves were conducted using an online questionnaire administered by the independent company Adelphi Targis. All panellists who completed the first questionnaire were invited to complete the second wave survey. The questionnaire was refined for the second wave as previously described [5].

In each survey round panellists indicated their level of agreement with a series of statements using a Likert scale (1-9, strongly disagree–strongly agree); responses were analysed using descriptive statistics with “disagreement” assigned to ratings 1–3, “neither agree nor disagree” 4-6, and “agreement” to ratings 7–9. Participants could alternatively indicate if a question was not relevant to their expertise. Responses from those who indicated a lack of relevant expertise were removed from the denominator when evaluating consensus on specific questions. Statements that reached 75% agreement were deemed to achieve consensus. The results from the second round relating to definition of terms are reported elsewhere [5].

Results

Thirty-seven experts from 15 countries completed the first round of the Delphi process of whom 35 completed the second. Panel demographics are shown in Table 1.

Consensus was achieved on 120 statements in the first round and on an additional 8 statements in the second round. The 39 recommendations summarized in Tables 2–7 reflect those statements for which consensus was reached, with some statements combined for efficiency.

Discussion

The broad agreement on most issues likely reflects the extent to which cDCDD practices have already been carefully examined [4]. This discussion provides a wider context, addressing the systemic and programmatic requirements for adult DCDD. It concentrates on the key elements of the cDCDD process.

System requirements for adult cDCDD programs

In 2024, the Global Observatory on Donation and Transplantation (GODT) reported 47,180 deceased organ donors from 78 of the 92 contributing countries [6]. Among these, 26 countries reported DCDD activity accounting for 13,366 donors, or 28% of the global total. Most DCDD cases were Maastricht type III (94%), where organ donation follows the WLSM [7, 8]. DCDD contribution to deceased donor activity within countries was highly variable: 66% in the Netherlands, 52% in Switzerland, 51% in Spain, 50% in Belgium and the UK, 43% in the United States, 36% in Australia and Canada, 31% in China, 25% in Sweden, 24% in Denmark, 23% in New Zealand, 21% in Ireland, and 20% or lower in Finland, Austria, Italy, France, Portugal, Czech Republic and Norway. DCDD is thus recognised as a key area for expansion of deceased donation activity [1, 2].

Establishing cDCDD programs requires comprehensive legal and regulatory frameworks (see Table 2). It is essential that laws and associated practices in end-of-life care allow the discontinuation of life-sustaining measures, such as mechanical ventilation and cardio-respiratory support, when such treatments are deemed no longer beneficial or excessively burdensome. This applies in situations where death is inevitable or when, in alignment with the patient’s wishes and family agreement, meaningful recovery is no longer possible. Importantly, such clinical practices should be grounded in the patient’s best interests, which include consideration of their preferences, and implemented independently from any consideration of potential suitability for donation, thus maintaining the integrity of end-of-life care decisions.

There was consensus that cDCDD programs should be introduced in a manner that prioritises opportunities for DNDD and that implementing a cDCDD program can augment DNDD. In some countries, an increase in rates of DCDD has coincided with a decline in DNDD, prompting concerns about premature diversion of potential DNDD candidates to the DCDD pathway, perhaps before allowing sufficient time for brain death to occur in patients with severe brain injury. GODT data from fifteen countries illustrate two main trends: in nine countries (such as Australia, Canada, Italy, and Sweden) DNDD rates have remained stable or increased after DCDD implementation, while in six (including Spain, Belgium, the Netherlands, and France) DNDD rates fell as DCDD rose [9]. Traditional DCDD practices with standard rapid recovery and cold storage generally yield fewer transplantable organs per donor and can result in inferior transplant outcomes for organs like the liver compared with DNDD [10]. Innovations such as use of perfusion technologies have the potential to reduce such disparities [11, 12]. Increasing DCDD activity may also be the result of changing end-of-life care practices independent of organ donation considerations, such as a shift to earlier discussions with families about prognosis and subsequent WLSM [13–15]. However, a notable proportion of patients considered for cDCDD ultimately proceed to the neurological determination of death (NDD), thus becoming DNDD donors. Some of these individuals might have been excluded from donation in the absence of a cDCDD pathway [16].

cDCDD is only feasible through the provision of ongoing supportive treatments and interventions prior to death that are performed solely for the purpose of donation, (see the consensus definition of ante-mortem interventions outlined below). The use of ante-mortem interventions in DCDD programs may require clear legislation as well as comprehensive ethical and practical guidance and their absence can act as a significant barrier to DCDD [17]. Where the lack of clear laws or guidelines has proven a barrier, legislation and guidelines should be introduced to explicitly address the permissibility of ante-mortem procedures per se and set out clear requirements for consent or authorisation of their use, which may involve substitute decision makers (SDMs). However, legislation should not specify permissible ante-mortem interventions to avoid unintended constraints on future practice given the continuous evolution of medical practice.

Consensus highlighted the importance of robust ethical guidance to support health professionals involved in end-of-life decisions or caring for donors within the context of cDCDD. Such guidance must ensure the clear separation of decisions regarding the cessation of non-beneficial treatments including WLSM, and those concerning organ donation, to prevent conflicts of interest [2, 18]. The panel also agreed on the critical need for comprehensive education for clinicians on cDCDD.

Preserving and identifying opportunities for cDCDD in adults

There was strong consensus that healthcare professionals should routinely consider organ donation as an integral part of end-of-life care, with donor identification recognized as a shared responsibility across clinical teams (see Table 3). There was support for clinical triggers or other mechanisms to aid the routine and timely communication with donation personnel for all patients potentially suitable for cDCDD, with supportive treatments maintained until donation could be discussed with the patient or their SDM, or cDCDD excluded due to lack of medical suitability.

Determining suitability for cDCDD can be more difficult than for DNDD candidates. Patients suitable for cDCDD include those with severe brain injuries who do not satisfy criteria for NDD, and patients with other irreversible disease processes including cardiac, respiratory and liver failure, and neuromuscular conditions (e.g., amyotrophic lateral sclerosis, high spinal cord injury). Clinicians more familiar with DNDD may overlook potential donors in these other clinical scenarios. Furthermore, judgements about the likelihood of death occurring after WLSM in a timeframe that allows for donation are difficult. Therefore, exploring cDCDD opportunities requires the acceptance that a proportion of attempted DCDDs may not proceed for this reason (see below) [19, 20].

Assessing the suitability of specific organs for transplantation also requires current knowledge of acceptance criteria and may necessitate advice from transplant units. Suitability can vary depending on whether there are recipient candidates in urgent need of transplantation, for whom the use of expanded criteria donor organs that may not be otherwise considered could be life-saving. Determination of medical suitability consequently requires the expertise of donation and transplantation personnel, and treating clinicians should not unilaterally exclude patients as unsuitable for donation.

Clinical triggers or similar mechanisms for initiating a referral to donation personnel can be helpful in ensuring the timely identification of all potential donors [21, 22]. For cDCDD, these need to be sufficiently broad to capture all potential donor opportunities. They are best tailored to local circumstances, considering donor suitability criteria that are contingent on local, regional or national transplant units organ acceptance practices, the point in the patient hospital course at which communication with donation personnel should occur, and the best mechanism for communication with donation personnel. In countries such as Spain, where cDCDD may be facilitated in patients approaching death outside critical care settings through the initiation of intensive care measures (intensive care to facilitate organ donation, ICOD), broader identification criteria are required to capture this donor pool [23, 24].

The communication with donation personnel should take place prior to any reduction in supportive treatments, which might otherwise compromise organ function and limit subsequent opportunities for donation. This should also be before any agreed time with the family for WLSM, which would leave insufficient opportunity to determine suitability, approach family to offer donation, and arrange the logistics of donation.

Overall, there was strong consensus that healthcare professionals caring for critically ill patients must take active responsibility for donor identification, supported by routine consultative mechanisms with donation experts. However, medical suitability should be determined by donation personnel, in consultation with transplant units where necessary, rather than by treating healthcare professionals. This promotes normalization of organ donation as a standard component of end-of-life care decision-making, enhancing donation rates while maintaining ethical and clinical integrity.

Assessment of medical suitability for cDCDD in adults

Suitability for cDCDD varies widely across systems and depends on several factors, including medical eligibility, end-of-life care practices, and the use of organ preservation techniques (see Table 4). Medical suitability for donation, whether DNDD or DCDD, includes an assessment of disease transmission risks and the function of individual organs, with differing eligibility between countries and even local transplant units depending on risk tolerance and the maturity of the transplantation programs. For cDCDD, an additional element is whether death will occur soon enough after WLSM to permit donation, and options for mitigating the impact of warm ischaemic injury through machine perfusion technologies [25].

Judging the likelihood of death occurrence soon after WLSM is imprecise, as this is influenced by many patient characteristics (see Box 1). Scoring systems incorporating these elements have been developed to support decision making, however these may not be better than the judgement of an experienced attending intensivist [19, 20, 26–28]. Given the imprecision and the unreliability of such assessments, the respondents agreed that suitability for donation should not rely on a single method of predicting the time to death post WLSM.

The approach to sedation and analgesia at the time of WLSM can also affect the time to death. Sedation may be administered either with the primary aim of symptom relief or as continuous deep sedation until death, and this distinction, combined with national stand down policies, has an important impact on donation outcomes. Stand down time refers to the timepoint after WLSM when donation efforts are abandoned if death has not occurred and organs are no longer considered eligible for transplantation [5]. In France and Spain, where continuous deep sedation until death is routine practice, death within stand down periods of 90–180 min is almost universal [29–31]. By contrast, in the UK and Australia, where medications are adjusted to manage symptoms instead of inducing deep unconsciousness, 20% of attempted cDCDD cases in the UK and 30% in Australia do not reach circulatory death within the required stand down times of 3 h and 90 min, respectively, resulting in no donation [32, 33]. Longer stand down times may allow a higher proportion of attempted cases to result in donation, with satisfactory transplant outcomes supported by the use of in situ normothermic regional perfusion (NRP) and ex situ machine perfusion devices.

The efficiency of cDCDD case selection is directly influenced by how strictly potential donors are chosen; limiting attempts to those highly likely to die rapidly after WLSM improves conversion rates but may reduce overall donation opportunities, while broader inclusion criteria enlarge the donor pool but leads to a lower proportion of actual donors per number of attempted DCDD cases.

There was agreement that guidance for the assessment of medical suitability for cDCDD in individual cases should be established at the national level, informed by an understanding of relevant factors that may differ across healthcare institutions. In evaluating medical suitability, both the individual characteristics of the potential donor and local healthcare system factors influencing the likelihood of successful organ recovery and transplantation must be considered (see Box 1). Healthcare system factors included end-of-life care practices, availability of perfusion technologies, and human resource expertise and availability, as well as logistical factors such as travel requirements. Notably, another factor that fell just below the consensus threshold with 74.3% agreement, was the availability and use of various ante-mortem interventions.

The criteria for individual donor assessment should clearly distinguish between potentially modifiable system-related factors affecting the feasibility of cDCDD and the clinical characteristics of the patient that determine suitability. Where there are system constraints limiting the ability to proceed with cDCDD, it was agreed that capturing data from such events could inform efforts to overcome barriers and improve future opportunities for cDCDD.

Communication about donation relating to cDCDD in adults

Decisions regarding cDCDD should be integrated thoughtfully into end-of-life care, ensuring ethical and legal standards are upheld throughout the process. There was consensus that, when medically relevant, information about cDCDD opportunities should be routinely offered to patients (where possible and appropriate), families, and SDMs as part of comprehensive end-of-life discussions (see Table 5).

A broadly accepted principle in all forms of deceased donation is that, before the possibility of donation is introduced, families should understand that death has occurred (NDD) or will occur, either as a clinical inevitability or as a consequence of decisions about end-of-life care. This principle is especially important in cDCDD, where donation decision-making always precedes death and must be separated from decision-making about WLSM.

There was agreement that it remains the treating physician’s responsibility to communicate with the patient’s family or SDM about decisions regarding WLSM. To preserve the integrity of end-of-life decisions, discussions with the patient’s family or SDM about organ donation should follow and not precede the decision about WLSM, and lawful consent formalizing donation should only be sought after this point.

There was consensus that discussions about donation should be initiated and led where possible by a trained donation professional who is not involved in the clinical care of the potential donor. The importance of clinicians with relevant expertise supporting informed decision-making about donation is well established [34–36]. Research favours the involvement of donation professionals due to higher family satisfaction with communication about donation and also consent rates [23, 37, 38]. A collaborative approach, where both the treating clinician and donation personnel together communicate with families about donation is an effective model [39–41]. There was high agreement that detailed, technical explanations about organ removal, post-mortem interventions, or specific protocols like NRP should only be conveyed by donation professionals.

A key rationale for staff other than the treating clinician raising donation is to avoid a perceived conflict of interest, if the same clinician is part of decision-making about end-of-life care and donation [42]. However, once the decision for WLSM has been made, concerns about conflicts may diminish, and trusted treating clinicians could be well positioned to raise the topic of donation due to their established rapport with the family [42].

There was consensus that patients (where possible and appropriate), or SDMs considering cDCDD should also receive information about options for organs or tissues to be used in research, the possibility of ‘stand down’ if death does not occur in time for donation, and interventions (ante- or post-mortem) that may enhance the likelihood of successful donation. It was agreed that the potential impact of certain end-of-life care choices, including timing and location of WLSM, on organ recovery and transplantation success needs to be clearly explained.

If a patient’s end-of-life care preferences may compromise donation opportunities or limit transplantable organs, this should be communicated sensitively to the SDM (or the patient if conscious), highlighting potential impacts on donation feasibility and outcomes. When the timing or location of WLSM is affected by the availability of surgical teams or donation logistics, options and implications should be discussed openly to facilitate informed choices.

For patients with devastating brain injuries who do not meet criteria for the NDD at the time of donor referral, cDCDD discussions should highlight, the possibility of donation through NDD pathways, if the patient subsequently meets NDD criteria.

Nationally developed guidance should clarify how SDMs should make decisions, ensuring that actions align with the patient’s expressed or presumed wishes whenever lawful. SDMs should prioritize the known or estimated preferences of the patient over their own judgement, especially regarding aspects of end-of-life care that could influence donation outcomes, as long as it is legally permissible [24, 43].

Managing the WLSM and end-of-life care process in cDCDD in adults

There was consensus that the approach to end-of-life care during and prior to WLSM in the context of cDCDD should align with established standards of routine end-of-life care. This includes the provision of sedation and analgesia to ensure patient comfort and dignity (see Table 6). Importantly, the WLSM and delivery of comfort care should be conducted exclusively by the treating clinical team and not personnel directly involved in the organ donation process. Comfort care for donation-related interventions before death should be equivalent to that provided when similar interventions are undertaken for therapeutic reasons. Families should be offered the option to be present during WLSM and until death is determined, supporting both transparency and emotional needs.

It was acknowledged that staff involved in cDCDD can advise the treating clinical team on how end-of-life care decisions may impact the success of organ donation, although the treating team retains primary responsibility for clinical care. This ensures that patient-centered care and comfort remain paramount, even as considerations about donation are factored in. The clinical approach should aim to enhance donation outcomes, without compromising patient comfort. For instance, WLSM timing and location decisions should balance patient and family needs with logistical requirements for organ recovery.

High support was expressed for all staff to meet before initiating WLSM to confirm roles, review donor documentation and legal authorizations, and ensure consensus on organ and tissue retrieval procedures. Teams should also establish contingency plans if death does not occur within the expected timeframe for donation. This preparation ensures a smooth, respectful process for patients and families while maximizing the efficiency and outcomes of cDCDD.

Overall, consensus supported practices that maintain the primacy of patient comfort and dignity during end-of-life care, while thoughtfully coordinating with donation teams to optimize transplantation outcomes.

Use of ante-mortem interventions for cDCDD in adults

It was agreed that “ante-mortem intervention for donation” should be defined as “any activity, procedure, or investigation undertaken before death for the purpose of organ and tissue donation that would not otherwise occur, including those to determine, maintain or improve the viability of organs for transplantation.” cDCDD by necessity requires some ante-mortem interventions, such as continuing cardio-respiratory supports until the logistics of donation surgery can be organised, and blood sampling for infectious disease screening and tissue typing for matching to recipient candidates.

Respondents concurred that there are several aspects of ante-mortem interventions to consider in decision-making about their use, including the potential to cause discomfort or harm, the invasiveness of the intervention, whether the intervention is commonly used in ICU, whether its use alters the end-of-life care of the patient, and its importance for the success of donation and transplantation. Acceptability may also be influenced by the strength of support for donation from the potential donor and their family (see Table 7).

There was also support for disclosure of some information about ante-mortem interventions with the patient (if applicable), their family or SDM as part of routine communication about the donation process, even if specific consent for an ante-mortem intervention is not required. Although short of the 75% consensus threshold, 74.3% of panellists agreed that, “Unless required by law, when a decision has been made to proceed with donation, consent may be presumed for ante-mortem interventions that do not involve additional, physically invasive clinical procedures and which are necessary conditions of any deceased donation, such as tissue typing tests for organ matching.” A potential implication is that specific consent should be obtained for invasive clinical procedures that are not part of the standard deceased donation process. This is supported by prior reviews of clinician attitudes to ante-mortem interventions [44, 45] and consistent with some national approaches, for example, the UK Donor Actions Framework for peri-mortem interventions related to deceased organ donation and ICOD in Spain that may involve intubation and the initiation of other intensive care measures [23, 24, 46].

A central focus of the consensus discussions was the broader purpose of ante-mortem interventions; not only their commonly emphasised potential benefits for transplant recipients but also their potential to serve the interests of the patient-potential donor and their family by supporting their donation goal(s) [44, 47]. There was consensus that “The potential benefits of using ante-mortem interventions should be considered inclusive of their potential impact on transplant recipients, on fulfilment of a person’s known or estimated goal to donate organs for transplantation, and on the person’s family.” Importantly, participants in the second round agreed that research should be undertaken to provide an evidence base for the potential benefits and harms of ante-mortem interventions. They expressed the desire for robust evidence to support informed decision-making, allowing donation authorities to adequately communicate with families about the potential trade-offs involved.

Strengths of this report include a robust methodology, with recommendations developed through international expert consensus; a key limitation is that they are based largely on expert opinion. Future work to evaluate the practical usefulness of these recommendations could include administering the survey to healthcare professionals considering the initiation of a cDCDD program, to identify which recommendations are most relevant and those that may be controversial or challenging in practice.

Conclusion

The advancement of cDCDD programs could significantly enhance the availability of organs for transplantation globally, yet it requires careful consideration of clinical, ethical, and logistical factors. The consensus guidance presented here emphasizes the primacy of patient comfort and dignity throughout end-of-life care, the importance of clear and compassionate communication with families, and the need for multidisciplinary collaboration across clinical and donation teams. National frameworks and tailored protocols are indispensable for addressing variability in healthcare settings and ensuring lawful, ethical practice.

Future efforts should prioritize building an evidence base around ante-mortem interventions, refining predictive tools for the time to death after WLSM, and facilitating education to improve clinical and donation team competency. There may be a need for professional bodies, healthcare organisations and governments to advocate for legal frameworks to be updated to facilitate implementation of consensus guidance. By harmonizing best practices and addressing systemic challenges, cDCDD programs can be effectively integrated into transplantation systems worldwide, ultimately improving organ availability while respecting the rights and values of donors and their families.

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