Organ DonationOPPO-PMONCT07345975
Characterization of Opposition to Organ Donation at Strasbourg University Hospital in 2024-2025
An observational study of Organ Donation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Donation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2025to 14 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie, Réanimation et Médecine Périopératoire - CHU de Strasbourg - France
Strasbourg, 67091
Charlotte POUSSARDIN, MD, 33 3.69.55.16.21, charlotte.poussardin@chru-strasbourg.fr
Charlotte POUSSARDIN, MD
About this study
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.
- Conditions
- Organ Donation
- Keywords
- Organ Donation, Organ transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of positions regarding organ donation (certain, uncertain, unknown)
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%
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start14 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ DonationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345975
- Sponsor's protocol ID
- 9824
- Acronym
- OPPO-PMO
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Opposition to Organ Donation at Strasbourg University Hospital in 2024-2025
- ClinicalTrials.gov ID
- NCT07345975
- Acronym / sponsor ID
- OPPO-PMO / 9824
- Conditions
- Organ Donation
- Keywords
- Organ Donation, Organ transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Donation, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte POUSSARDIN, MD (33 3.69.55.16.21, charlotte.poussardin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of positions regarding organ donation (certain, uncertain, unknown) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.