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Clinical Trials/NCT06780722
NCT06780722RecruitingNot Applicable

Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study

Nantes University Hospital12 sites in 1 country50 target enrollmentStarted: December 19, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
12
Primary Endpoint
PaO2 level
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Detailed Description

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Outcomes

Primary Outcomes

PaO2 level

Time Frame: 24 hours

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.

Secondary Outcomes

  • Spo2 Level(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)
  • Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (12)

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Study of the Occurrence of... | Clinical Trial