How oxygen levels relate to when circulation stops during controlled (Maastricht III) organ donation
Official title: Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study
Run by Nantes University Hospital · NCT06780722 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 12 sites (Angers and 11 other locations) |
| Status | Recruiting |
| Started | December 19, 2025 |
| Main results expected | June 6, 2027 |
| Study ends | June 19, 2027 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT06780722 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 6 more locations
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CHU NANTES +- Médecine Intensive Réanimation
Nantes, France Recruiting -
CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes
Orléans, 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 -
CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes
Poitiers, France Not yet recruiting
Study contacts
- Study coordinator: Jean Baptiste LASCARROU
- Email: Jeanbaptiste.lascarrou@chu-nantes.fr
- Phone: 02 40 08 73 76
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.