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Clinical Trials/NCT07345975
NCT07345975RecruitingNot Applicable

Characterization of Opposition to Organ Donation at Strasbourg University Hospital in 2024-2025

University Hospital, Strasbourg, France1 site in 1 country100 target enrollmentStarted: October 14, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Distribution of positions regarding organ donation (certain, uncertain, unknown)

Study Overview

Brief Summary

In 2024, 29,000 people are waiting for organ transplants in France, and only 6,034 transplants were performed during the year. 852 people died while waiting for a transplant. The gap between the number of available transplants and the number of patients waiting for transplants has been widening since the 1990s; there is talk of a shortage of transplants. There is therefore an urgent need to find more transplants and mobilize the entire population to this end.

French law supports presumed consent, meaning that we are all donors unless we have expressed otherwise during our lifetime. In fact, 80% of French people say they are in favor of organ donation after their death, but few discuss it with their loved ones. When families are approached about multi-organ removal to gather any opposition from the deceased, the refusal rate is 37% (compared to an expected 20%).

It is difficult to determine whether this opposition truly comes from the deceased themselves, their loved ones, uncertainty, or the situation. As this is the leading cause of non-donation, it is essential to better characterize this opposition in order to reduce it and allow for more organ donation and, ultimately, transplantation.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

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

Inclusion Criteria

  • Patients who are brain dead and/or eligible for a Maastricht 3 protocol (discontinuation of active treatment with death due to circulatory arrest in intensive care)
  • Hospitalized in the intensive care unit of the Strasbourg University Hospital or transferable to the Strasbourg University Hospital for multi-organ removal (anticipated approach)
  • Existence of relatives with whom discussion is possible
  • Presence of organ procurement coordination at the initial donation interview

Exclusion Criteria

  • Absence of relatives of the deceased (no interview with them)
  • Absence of organ procurement coordination during the initial discussion with relatives regarding organ and tissue procurement

Outcomes

Primary Outcomes

Distribution of positions regarding organ donation (certain, uncertain, unknown)

Time Frame: Up to 12 months

Distribution of positions regarding organ donation (certain, uncertain, unknown): For illustration purposes: * Certain position: ≈ 65% * Favorable: ≈ 55% * Opposed: ≈ 10% * Uncertain position: ≈ 25% * Unknown/unexpressed position: ≈ 10%

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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