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Effect of Collaborative Requesting on DCD Refusal Rates: Randomized Controlled Trial

NCT05660252 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2022-12-22

No results posted yet for this study

Summary

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

  • Organ Donation
  • Required Organ Donation Request
  • Professional Family Relations
  • Intensive Care Units

Interventions

OTHER

Collaborative request

The relative is approached by the clinical team and an organ procurement coordinator together.

Sponsors & Collaborators

  • University of Burgundy

    collaborator OTHER

  • Famirea Study Group

    collaborator OTHER

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Laurent MARTIN-LEFEVRE, MD · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2025-06-16
Completion
2026-06-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660252 on ClinicalTrials.gov