Clinical Trial

ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved

Study acronym: DONOR-OBS
Recruiting
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Record status
This record was last updated May 16, 2025 (before its estimated February 15, 2026 completion). Its status may not reflect the trial's current state.
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). 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-06.
Status change: Not Yet Recruiting → Recruiting 2025-05-13
Trial Details
NCT Number NCT06768515
Lead Sponsor Société Française d'Anesthésie et de Réanimation
Conditions Death, Brain
Enrollment 1,000 participants
Start Date 2025-04-23
Primary Completion 2026-02-15 (estimated)
Study Completion 2026-02-15 (estimated)
Updated on ClinicalTrials.gov 2025-05-16