How oxygen levels relate to when circulation stops during controlled (Maastricht III) organ donation
Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study
This research will test how oxygen levels change around the time the heart stops in adults who undergo controlled Maastricht III organ donation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT06780722 on ClinicalTrials.gov |
What this trial studies
This observational study will measure blood oxygen levels in donors during the Maastricht III controlled withdrawal of life-sustaining therapy and at the moment of cardiocirculatory arrest. Serial blood samples will be collected from consenting adult donors and linked to precise timing of circulation loss, with limited clinical data recorded. De-identified data will also be collected from adult recipients who receive organs from those donors. The work is carried out at several French university hospitals under the existing legal framework for Maastricht III donation.
Who should consider this trial
Good fit: Ideal participants are adults undergoing a controlled Maastricht III organ donation under French law and adult transplant recipients who receive organs from those donors and consent to data use.
Not a fit: Children, living donors, pregnant or breast-feeding women, people who have registered a refusal, and patients under legal protection are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify physiological changes at circulatory arrest and help refine donation protocols to improve organ preservation and allocation.
How similar studies have performed: Prior observational work on donation after circulatory death has described physiological changes at arrest, but detailed blood-sampling focused on hypoxemia timing in Maastricht III procedures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
FOR THE DONORS : Inclusion Criteria : * Patient over 18 years of age * Organ donation procedure initiated in accordance with the legislation and procedures in force in France for the Maastricht III category * No opposition formulated by the relative to the patient's participation in the study Exclusion Criteria : * Patient registered on the national register of refusals or living refusal of donation * Pregnant or breast-feeding women * Patients under guardianship, curatorship or legal protection * Medical contraindication to organ donation according to the recommendations of the Agence de Biomédecine currently in force in France FOR THE RECEIVER Inclusion Criteria : * No opposition to the collection of data concerning him/her * Patient over 18 at pre-transplant consultation * Patient who has received an organ from a donor participating in the HEPHAISTOS protocol Exclusion Criteria : \- Patients under guardianship, curatorship or legal protection
Where this trial is running
Angers and 11 other locations
- CHU ANGERS - Réanimation médicale — Angers, France (Recruiting)
- CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes — Annecy, France (Recruiting)
- CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente — Avignon, France (Recruiting)
- CHD Vendée - Les Oudairies - Médecine Intensive Réanimation — La Roche-sur-Yon, France (Recruiting)
- CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation — Lille, France (Recruiting)
- CHU de Nantes - Hôpital Laennec — Nantes, France (Recruiting)
- CHU NANTES +- Médecine Intensive Réanimation — Nantes, France (Recruiting)
- CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes — Orléans, France (Recruiting)
- CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes — Poitiers, France (Recruiting)
- CHU RENNES - CHU Pontchaillou - Réanimation médicale — Rennes, France (Recruiting)
- CHRU TOURS - Hôpital Bretonneau - Médecine Intensive Réanimation — Tours, France (Recruiting)
- CHBA Vannes-Auray - Réanimation Polyvalente — Vannes, France (Recruiting)
Study contacts
- Study coordinator: Jean Baptiste LASCARROU
- Email: Jeanbaptiste.lascarrou@chu-nantes.fr
- Phone: 02 40 08 73 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.