Clinical trial Recruiting at 11 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorNantes University Hospital
Academic / other
Locations12 sites (Angers and 11 other locations)
StatusRecruiting
StartedDecember 19, 2025
Main results expectedJune 6, 2027
Study endsJune 19, 2027
Registry record updatedJune 25, 2026
Trial IDNCT06780722 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

  • 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
  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.