Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05660252

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • None

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Trial Site Locations

Total: 1 location

1

CHU Nantes

Nantes, Pays de la Loire Region, France, 44093

Actively Recruiting

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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

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