An observational study in Death, Brain, sponsored by Société Française d'Anesthésie et de Réanimation. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Société Française d'Anesthésie et de Réanimation · Observational
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 80 across 33 observational studies indexed under Brain Death.
Browse Brain Death studies →Société Française d'Anesthésie et de Réanimation is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients over 18 years of age, hospitalized in the ICU In a state of brain death No objection to organ donation during their lifetime
Other: No interventtion
to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation
Mean arterial pressure
Mean arterial pressure (MAP) between 60 and 110 mmHg
Time frame: 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
Time frame: Within 7 last days before brain death and before multi-organ retrieval
Left ventricular ejection fraction
Left ventricular ejection fraction (LVEF) ≥ 50%
Time frame: 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))
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Arterial pH
Arterial pH between 7.3 and 7.5
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
PaO2/FiO2
PaO2/FiO2 ≥ 300
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Sodium levels
Sodium levels ≤ 155 mmol/L
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Diuresis
Diuresis ≥ 0.5 mL/kg/h
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Blood glucose
Blood glucose ≤ 1.5 g/L
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
demographics of Brain dead
The 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
Describe the 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
Descibe the 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
Describe the 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
Describe the 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
Describe the 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
Describe the 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
Describe the 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
Describe the number and nature of organs retrieved, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
Time frame: 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
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
Describe the 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
Desctibe the 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
Plan to share: Undecided
Started Apr 2025 (actual). Primary completion is estimated for Feb 2026, 9 months after the start.
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Société Française d'Anesthésie et de Réanimation