Death, BrainDONOR-OBSNCT06768515
ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved
An observational study of Death, Brain, run by Société Française d'Anesthésie et de Réanimation at 2 sites in France.
Trial summary
Solid organ transplantation is the treatment of choice for end stage organ failure to improve patients' quality of life and survival. Each year, more than 5,000 solid organ transplants are performed in France, mainly from brain death donors (BDD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Brain
- What is being tested?
- No interventtion
- How many people
- 1,000 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Apr 2025to 15 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in a state of brain dead. Patients meeting the inclusion criteria from January 1, 2022, to December 31, 2024, will be included in the study.
Who may be able to join
- Patients over 18 years of age, hospitalized in the ICU
- In a state of brain death
- No objection to organ donation during their lifetime
- Patients with social security coverage
Who cannot join
- Objection to the use of their data during their lifetime
- Registration in the national refusal registry
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Saint-Louis, AP-HP
Paris, 75010
Maxime COUTROT, MD
- Recruiting
Hôpital Pitié Salpêtrière AP-HP
Paris, 75013
Frank Ferrari, MD
About this study
Solid organ transplantation is the treatment of choice for end stage organ failure to improve patients' quality of life and survival. Each year, more than 5,000 solid organ transplants are performed in France, mainly from brain death donors (BDD).
Approximately 1,500 BDD donors have one or more organs removed each year. Despite the growing demand for transplanted organs, the number of organs available from deceased donors has remained stable over the past few decades. This highlights the need to optimize the management of potential BDD, in order to increase both the quality and number of transplanted organs. Several studies have found an association between the characteristics and management of BDD donors and the number of organs, or even the function of transplanted organs. Data suggest that hemodynamic, respiratory, and metabolic therapeutic targets during BDD management prior to multi-organ procurement were associated with a higher number of transplanted organs compared to standard care. However, this has never been confirmed in a French population. Furthermore, while the impact of these therapeutic goals has been studied after the donor is in a state of brain death, the events occurring in the ICU before reaching brain death status and their impact on the number of organs retrieved have not been investigated. Lastly, the intensity of the therapeutic interventions used to achieve these goals, and certain management delays, have only been partially studied.
Our hypothesis is that achieving a bundle of therapeutic goals, and the intensity of the interventions used to reach these goals, both before and after BDD, are associated with a greater number of organs retrieved.
- Conditions
- Death, Brain
- Being tested
- No interventtion
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventtionOther
to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation
| Study group | Role | What they receive |
|---|---|---|
| Organ donation | Patients over 18 years of age, hospitalized in the ICU In a state of brain death No objection to organ donation during their lifetime Receives: Other: No interventtion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Mean arterial pressure (MAP) between 60 and 110 mmHg
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Central venous pressure
Central venous pressure (CVP) between 4 and 12 mmHg
Measured: Within 7 last days before brain death and before multi-organ retrieval
Left ventricular ejection fraction
Left ventricular ejection fraction (LVEF) ≥ 50%
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
vasopressor
Low doses and a single vasopressor. (≤10 µg/kg/min of dopamine or ≤60 µg/min of Neosynephrine or ≤10 µg/min of norepinephrine))
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Arterial pH
Arterial pH between 7.3 and 7.5
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
PaO2/FiO2
PaO2/FiO2 ≥ 300
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Sodium levels
Sodium levels ≤ 155 mmol/L
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Diuresis
Diuresis ≥ 0.5 mL/kg/h
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Blood glucose
Blood glucose ≤ 1.5 g/L
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Secondary outcomes (12)
demographics of Brain dead
The demographics of Brain dead
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Causes of neurological injury leading to brain death
Describe the causes of neurological injury leading to brain death
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Timelines and durations of patient management before and after brain death
Descibe the timelines and durations of patient management before and after brain death
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of organ failures before and after brain death
Describe the incidence of organ failures before and after brain death
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of acute kidney failure before and after brain death
Describe the incidence of acute kidney failure before and after brain death
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of infections, sepsis, and septic shock before and after brain death
Describe the incidence of infections, sepsis, and septic shock before and after brain death
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of diabetes insipidus
Describe the incidence of diabetes insipidus
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Treatments administered before and after brain death
Describe the treatments administered before and after brain death
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Number and nature of organs retrieved
Describe the number and nature of organs retrieved, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Number and nature of organs available for transplantation
Describe the number and nature of organs available for transplantation, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Number of organs placed on ex situ preservation and the type of preservation method used
Describe the number of organs placed on ex situ preservation and the type of preservation method used
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Number, causes, and associated factors of unsuccessful organ retrieval procedures
Desctibe the number, causes, and associated factors of unsuccessful organ retrieval procedures
Measured: Between admission to intensive care and brain death and before multi-organ retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start23 Apr 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Death, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768515
- Sponsor's protocol ID
- 2024-04
- Acronym
- DONOR-OBS
- Status last verified
- May 2025
- First submitted
- 23 Dec 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malinoski DJ, Patel MS, Daly MC, Oley-Graybill C, Salim A; UNOS Region 5 DMG workgroup. The impact of meeting donor management goals on the number of organs transplanted per donor: results from the United Network for Organ Sharing Region 5 prospective donor management goals study. Crit Care Med. 2012 Oct;40(10):2773-80. doi: 10.1097/CCM.0b013e31825b252a.
PubMed 22846779Oniscu GC, Rockell K, Martin DE. Challenges in undertaking research in transplantation. Lancet. 2025 Mar 1;405(10480):681-683. doi: 10.1016/S0140-6736(24)00931-0. Epub 2024 May 21. No abstract available.
PubMed 38788740iomedecine, P. Chiffres 2022 de l'activité de prélèvement et de greffe d'organes et de tissus et Baromète 2023 sur la connaissance et la perception du don d'organes en France.
Patel MS, De La Cruz S, Sally MB, Groat T, Malinoski DJ. Active Donor Management During the Hospital Phase of Care Is Associated with More Organs Transplanted per Donor. J Am Coll Surg. 2017 Oct;225(4):525-531. doi: 10.1016/j.jamcollsurg.2017.06.014. Epub 2017 Jul 21.
PubMed 28739153Bera KD, Shah A, English MR, Harvey D, Ploeg RJ. Optimisation of the organ donor and effects on transplanted organs: a narrative review on current practice and future directions. Anaesthesia. 2020 Sep;75(9):1191-1204. doi: 10.1111/anae.15037. Epub 2020 May 19.
PubMed 32430910Patel MS, Zatarain J, De La Cruz S, Sally MB, Ewing T, Crutchfield M, Enestvedt CK, Malinoski DJ. The impact of meeting donor management goals on the number of organs transplanted per expanded criteria donor: a prospective study from the UNOS Region 5 Donor Management Goals Workgroup. JAMA Surg. 2014 Sep;149(9):969-75. doi: 10.1001/jamasurg.2014.967.
PubMed 25054379
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved
- ClinicalTrials.gov ID
- NCT06768515
- Acronym / sponsor ID
- DONOR-OBS / 2024-04
- Conditions
- Death, Brain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Solid organ transplantation is the treatment of choice for end stage organ failure to improve patients' quality of life and survival. Each year, more than 5,000 solid organ transplants are performed in France, mainly from brain death donors (BDD).
Approximately 1,500 BDD donors have one or more organs removed each year. Despite the growing demand for transplanted organs, the number of organs available from deceased donors has remained stable over the past few decades. This highlights the need to optimize the management of potential BDD, in order to increase both the quality and number of transplanted organs. Several studies have found an association between the characteristics and management of BDD donors and the number of organs, or even the function of transplanted organs. Data suggest that hemodynamic, respiratory, and metabolic therapeutic targets during BDD management prior to multi-organ procurement were associated with a higher number of transplanted organs compared to standard care. However, this has never been confirmed in a French population. Furthermore, while the impact of these therapeutic goals has been studied after the donor is in a state of brain death, the events occurring in the ICU before reaching brain death status and their impact on the number of organs retrieved have not been investigated. Lastly, the intensity of the therapeutic interventions used to achieve these goals, and certain management delays, have only been partially studied.
Our hypothesis is that achieving a bundle of therapeutic goals, and the intensity of the interventions used to reach these goals, both before and after BDD, are associated with a greater number of organs retrieved.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organ donation | – | Other: No interventtionPatients over 18 years of age, hospitalized in the ICU In a state of brain death No objection to organ donation during their lifetime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a state of brain dead. Patients meeting the inclusion criteria from January 1, 2022, to December 31, 2024, will be included in the study.
Key inclusion criteria (4 listed)
- Patients over 18 years of age, hospitalized in the ICU
- In a state of brain death
- No objection to organ donation during their lifetime
- Patients with social security coverage
Key exclusion criteria (2 listed)
- Objection to the use of their data during their lifetime
- Registration in the national refusal registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventtionto enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation | Other | Organ donation |
Primary outcome
Mean arterial pressure
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Mean arterial pressure (MAP) between 60 and 110 mmHg
Central venous pressure
Time frame: Within 7 last days before brain death and before multi-organ retrieval
Central venous pressure (CVP) between 4 and 12 mmHg
Left ventricular ejection fraction
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Left ventricular ejection fraction (LVEF) ≥ 50%
vasopressor
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Low doses and a single vasopressor. (≤10 µg/kg/min of dopamine or ≤60 µg/min of Neosynephrine or ≤10 µg/min of norepinephrine))
Arterial pH
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Arterial pH between 7.3 and 7.5
PaO2/FiO2
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
PaO2/FiO2 ≥ 300
Sodium levels
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Sodium levels ≤ 155 mmol/L
Diuresis
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Diuresis ≥ 0.5 mL/kg/h
Blood glucose
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Blood glucose ≤ 1.5 g/L
12 secondary outcomes
demographics of Brain dead
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Causes of neurological injury leading to brain death
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Timelines and durations of patient management before and after brain death
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of organ failures before and after brain death
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of acute kidney failure before and after brain death
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of infections, sepsis, and septic shock before and after brain death
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Incidence of diabetes insipidus
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Treatments administered before and after brain death
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Number and nature of organs retrieved
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Number and nature of organs available for transplantation
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Number of organs placed on ex situ preservation and the type of preservation method used
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Number, causes, and associated factors of unsuccessful organ retrieval procedures
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 22846779Malinoski DJ, Patel MS, Daly MC, Oley-Graybill C, Salim A; UNOS Region 5 DMG workgroup. The impact of meeting donor management goals on the number of organs transplanted per donor: results from the United Network for Organ Sharing Region 5 prospective donor management goals study. Crit Care Med. 2012 Oct;40(10):2773-80. doi: 10.1097/CCM.0b013e31825b252a.
- Background: PubMed 38788740Oniscu GC, Rockell K, Martin DE. Challenges in undertaking research in transplantation. Lancet. 2025 Mar 1;405(10480):681-683. doi: 10.1016/S0140-6736(24)00931-0. Epub 2024 May 21. No abstract available.
- Backgroundiomedecine, P. Chiffres 2022 de l'activité de prélèvement et de greffe d'organes et de tissus et Baromète 2023 sur la connaissance et la perception du don d'organes en France.
- Results publication: PubMed 28739153Patel MS, De La Cruz S, Sally MB, Groat T, Malinoski DJ. Active Donor Management During the Hospital Phase of Care Is Associated with More Organs Transplanted per Donor. J Am Coll Surg. 2017 Oct;225(4):525-531. doi: 10.1016/j.jamcollsurg.2017.06.014. Epub 2017 Jul 21.
- Results publication: PubMed 32430910Bera KD, Shah A, English MR, Harvey D, Ploeg RJ. Optimisation of the organ donor and effects on transplanted organs: a narrative review on current practice and future directions. Anaesthesia. 2020 Sep;75(9):1191-1204. doi: 10.1111/anae.15037. Epub 2020 May 19.
- Results publication: PubMed 25054379Patel MS, Zatarain J, De La Cruz S, Sally MB, Ewing T, Crutchfield M, Enestvedt CK, Malinoski DJ. The impact of meeting donor management goals on the number of organs transplanted per expanded criteria donor: a prospective study from the UNOS Region 5 Donor Management Goals Workgroup. JAMA Surg. 2014 Sep;149(9):969-75. doi: 10.1001/jamasurg.2014.967.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, Brain, run by Société Française d'Anesthésie et de Réanimation at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime COUTROT, MD (+33 1 42 49 93 94, maxime.coutrot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: Between admission to intensive care and brain death and before multi-organ retrieval). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768515, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.