Actively Recruiting
Collaborative Approach to Identifying Organ Donation Consent by Relatives of Potential Cardiocirculatory Arrest Donors (Maastricht Category 3): A Randomized Controlled Open-Label Trial
Led by Nantes University Hospital · Updated on 2022-12-22
548
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
U
University of Burgundy
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a collaborative approach involving both the intensive care unit (ICU) team and an organ procurement coordinator (OPC) can reduce the rate of family refusal for organ donation after controlled circulatory death (DCD). The study addresses the challenge that many organ donations are not realized due to family refusal, which is a significant issue in France where refusal rates exceed national targets. By focusing on DCD, where death occurs in the ICU and the request is always made after withdrawal of life-sustaining treatments (WLST), the study seeks to provide clear insights into improving consent rates. Participants are randomly assigned to one of two groups: one where the request for organ donation is made jointly by the ICU team and an OPC (collaborative request), and the other where the ICU team alone makes the request (routine request). This design allows comparison of the refusal rates between these approaches. The trial is open-label and conducted across multiple centers, with individual randomization of potential donors. The study specifically excludes brain death donation cases and focuses solely on DCD, ensuring a uniform participant population. During the study, the families of potential donors will be approached according to their assigned group, and researchers will measure the rate of family refusal of organ donation one day after the request. Additional assessments include anxiety and depression scales, impact of event scales, and grief inventories completed by participating relatives at 3 and 12 months after the patient's death. The study also collects qualitative feedback from families and healthcare staff to better understand experiences and perceptions. This comprehensive follow-up aims to monitor both immediate and longer-term outcomes related to the organ donation request process.
CONDITIONS
Brief Title
Effect of Collaborative Requesting on DCD Refusal Rates: Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older in ICU with a decision to withdraw life-sustaining treatments and expected circulatory and respiratory cessation suitable for organ recovery
- Patient's relative aged 18 years or older who consents to participate
- Relative has had at least one conversation with the clinical team before joining the study
- Relative has good knowledge of spoken French
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants' relatives are approached about donation either by the ICU team and an organ procurement coordinator together (collaborative approach) or by the clinical team only (routine approach) to determine whether they refuse donation after the withdrawal of life-sustaining treatments.
1 visit (in-person)
Duration - Up to 12 months after the death of the patient
Participants' relatives complete questionnaires assessing anxiety, depression, grief, and psychosocial experience at 3 and 12 months after the patient's death.
Assessments at 3 and 12 months after death
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
Research Team
L
Laurent MARTIN-LEFEVRE, MD
J
Jean REIGNIER, MD - Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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