NCT05660252: PRODON

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

Recruiting now NA Last updated 22 December 2022

What this trial tests

NA trial testing Collaborative request in Organ Donation in 548 participants. Currently enrolling.

Timeline

16 June 2022

Primary endpoint
16 June 2025

16 June 2026

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	548
Start date	16 June 2022
Primary completion	16 June 2025
Estimated completion	16 June 2026
Sites	1 location across France

Drugs / interventions tested

• Collaborative request

Conditions studied

• Organ Donation — all drugs for Organ Donation →
• Required Organ Donation Request — all drugs for Required Organ Donation Request →
• Professional Family Relations — all drugs for Professional Family Relations →
• Intensive Care Units — all drugs for Intensive Care Units →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Organ Donation or Required Organ Donation Request. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Experience of Clinicians and Relatives with Donation after Controlled Circulatory Death: A Prospective Qualitative Study.
   Denise T, Cœur M, Martin-Lefevre L, Reignier J, et al · · 2026 · PMID 41788502 · DOI 10.1016/j.aicoj.2025.100002