Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure
HEPHAISTOS
1 other identifier
observational
50
1 country
12
Brief Summary
Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2025
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 19, 2027
March 30, 2026
March 1, 2026
1.5 years
January 13, 2025
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
PaO2 level
PaO2 level and its 95% confidence interval in the event of circulatory cardiac arrest, defined as a pulse pressure below 5 mmHg, during a Maastricht III procedure.
24 hours
Secondary Outcomes (3)
Spo2 Level
24 hours
Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest
24 hours
Correlation between the rate of delayed recovery of renal function in the recipient and the presence of hypoxemia at the time of cardiocirculatory arrest in the donor.
7 days
Interventions
* The first sample is taken at the start of the therapeutic stop. * The second sample is taken when the mean arterial pressure drops to 45mmHg. * The third sample is taken when circulatory arrest occurs. * The fourth sample is taken at the start of extracorporeal circulation. These four samples will be destroyed at the end of the study.
Eligibility Criteria
Patients who may be candidates for an organ donation procedure in the event of death in intensive care following the implementation of a procedure to discontinue active therapies.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- \- Patients under guardianship, curatorship or legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CHU ANGERS - Réanimation médicale
Angers, France
CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes
Annecy, France
CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente
Avignon, France
CHD Vendée - Les Oudairies - Médecine Intensive Réanimation
La Roche-sur-Yon, France
CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation
Lille, France
CHU de Nantes - Hôpital Laennec
Nantes, France
CHU NANTES +- Médecine Intensive Réanimation
Nantes, France
CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes
Orléans, France
CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes
Poitiers, France
CHU RENNES - CHU Pontchaillou - Réanimation médicale
Rennes, France
CHRU TOURS - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, France
CHBA Vannes-Auray - Réanimation Polyvalente
Vannes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
December 19, 2025
Primary Completion (Estimated)
June 6, 2027
Study Completion (Estimated)
June 19, 2027
Last Updated
March 30, 2026
Record last verified: 2026-03