Collaborative requesting to improve organ donation consent rates
Collaborative Approach to Identifying Organ Donation Consent by Relatives of Potential Cardiocirculatory Arrest Donors (Maastricht Category 3): A Randomized Controlled Open-Label Trial
This study tests if having both a doctor and an organ donation coordinator ask families about organ donation together can help more families say yes during tough times in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 548 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Pays de la Loire Region) |
| Trial ID | NCT05660252 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of collaborative requesting on the refusal rates of organ donation after brain death (DBD) and controlled circulatory death (DCD). The approach involves a joint request for organ donation made by the physician in charge of the patient and an organ procurement coordinator (OPC), aiming to enhance consent rates among families. The study will include patients in the ICU who are facing withdrawal of life-sustaining treatments and their relatives, assessing the effectiveness of this method in increasing organ donation rates. The trial is set against the backdrop of high refusal rates in France, with the goal of improving practices and outcomes in organ donation.
Who should consider this trial
Good fit: Ideal candidates for this study are ICU patients aged 18 years or older for whom a decision to withdraw life-sustaining treatments has been made.
Not a fit: Patients who are not in the ICU or those who do not have a decision made regarding life-sustaining treatment withdrawal may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the rates of organ donation, thereby addressing the organ shortage crisis.
How similar studies have performed: Other studies have suggested that collaborative approaches in organ donation requests can improve consent rates, indicating potential success for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient 18 years or more Patients in the ICU for whom a decision to withdraw life-sustaining treatments (WLST) has been made and for whom the cessation of circulatory and respiratory functions is anticipated to occur within a time frame that will enable organ recovery * Patient's relative 18 years or more Has consented to participate in the trial Has had at least one conversation with the clinical team before study inclusion Has good knowledge of spoken French Exclusion Criteria: * None
Where this trial is running
Nantes, Pays de la Loire Region
- CHU Nantes — Nantes, Pays de la Loire Region, France (Recruiting)
Study contacts
- Principal investigator: Laurent MARTIN-LEFEVRE, MD — Nantes University Hospital
- Study coordinator: Laurent MARTIN-LEFEVRE, MD
- Email: laurent.martinlefevre@chu-nantes.fr
- Phone: 44768435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.