Status:
NOT_YET_RECRUITING
Anesthesia sTrategy foR Organ Procurement In braiN dEath
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Brain-dead Organ Donors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Brain-dead donors (BDD) remain the primary source of grafts for organ transplantation in France and worldwide. The main objective of BDD management, from the diagnosis of brain death in the intensive ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07166991
Start Date
September 1 2025
End Date
September 1 2029
Last Update
September 11 2025
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