Actively Recruiting
Effect of Collaborative Requesting on DCD Refusal Rates: Randomized Controlled Trial
Led by Nantes University Hospital · Updated on 2022-12-22
548
Participants Needed
1
Research Sites
208 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
The most common reason for not obtaining donation after brain death (DBD) or donation after controlled circulatory death (DCD) in France is refusal of consent by the relatives. Many observational studies suggest that consent rates may increase when the request is made by specially trained and highly experienced professionals. One technique that may maximize the consent rate is collaborative requesting made jointly by the physician in charge of the patient and an organ procurement coordinator (OPC). Although the general principles are the same for DCD as for DBD, several differences and specificities exist. First, withdrawal of life-sustaining treatments (WLST) decisions should be entirely independent from organ-donation considerations, in order to eliminate potential conflicts of interest. However, separating conversations about WLST and donation may not always be possible. Potential DCD situations often occur after an extended ICU stay with the development of close ties between families and staff. The ICU physician may therefore feel that suggesting donation during the WLST conversation serves the family-ICU staff relationship. An unblinded multicenter randomized controlled trial tested the null hypothesis of no difference in organ-donation consent rates between collaborative requesting (clinical team and OPC together) vs. the clinical team only (routine requesting). The potential donors met criteria for brain-stem death or had impending brain-stem death; none were candidates for DCD. Collaborative requesting did not increase the consent rate. The PRODON study will test whether collaborative requesting by the ICU team and OPC decreases the rate of DCD refusal by families compared to routine requesting by the ICU team only.
CONDITIONS
Official Title
Effect of Collaborative Requesting on DCD Refusal Rates: Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years or more
- Patient in the ICU with a decision to withdraw life-sustaining treatments and expected timing of death suitable for organ recovery
- Patient's relative 18 years or more
- Relative has consented to participate in the trial
- Relative has had at least one conversation with the clinical team before study inclusion
- Relative has good knowledge of spoken French
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jean REIGNIER, MD - Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here