Anesthesia sTrategy foR Organ Procurement In braiN dEath (NCT07166991) | Clinical Trial Compass
RecruitingPhase 3
Anesthesia sTrategy foR Organ Procurement In braiN dEath
France270 participantsStarted 2026-02-17
Plain-language summary
The optimal anesthetic strategy during organ procurement in brain-dead donors remains unknown. The administration of anesthetic drugs in this setting aims to preserve hemodynamic stability in the face of reflex responses mediated by preserved spinal activity. Volatile anesthetics may blunt these reflexes, but their potential benefits in this context have never been investigated.
This randomized trial evaluates the effects of volatile anesthesia (sevoflurane), opioid administration (sufentanil), or no anesthetic drugs on intraoperative hemodynamic stability during organ procurement in brain-dead donors. The primary outcome is the proportion of operative time within a predefined arterial blood pressure range.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible adult brain-dead donor hospitalized in intensive care unit in one of the participating center:
* Confirmed diagnosis of brain death according to French public health code.
* Ongoing organ donation procedure managed by the local organ procurement coordination team with confirmation of the potential procurement of at least one intra-abdominal or intra-thoracic organ.
* Transfer to the operating room for the organ procurement procedure scheduled for the next 6 hours and anesthesia team alerted.
* Information of the patient's next of kin by the investigator and absence of opposition to research confirmed by the testimony of the next of kin according to French public health code.
Exclusion Criteria:
* Age \< 18 years.
* DCD (donation after circulatory death) donors.
* Ongoing extracorporeal circulation at the time of death.
* Hemodynamic instability at the screening visit defined by a noradrenalin dose \> 1 µg/kg/min.
* Contraindication to the implementation of the anesthetic interventions evaluated in the trial:
* Prior history of opioid or volatil anesthetic agents allergy.
* Prior personal or family history of malignant hyperthermia or history of myopathy at risk of malignant hyperthermia.
* Opposition to the research expressed by the patient during his or her lifetime and documented by the next of kin.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A hierarchical endpoint of hemodynamic stability during the organ procurement procedure