Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02854267
Other study ID # CANEVAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date December 31, 2018

Study information

Verified date January 2020
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings


Description:

The main obstacle for organ procurement in brain dead patients in France is organ donation refusal by the next of kin. When refusal is reflecting the patient's position, ending the organ donation procedure respects the bioethic French laws. Nevertheless, the actual position of the deceased patient often remains unknown. In these cases, organ donation refusal does not necessarily respect the deceased wishes. Many factors have been associated to next of kin organ donation refusal in such situations. Among those factors, some concerning the meeting with the next of kin have been isolated. French data on this subject are lacking.

A dedicated guide for the conduct of meetings with the next of kin has been elaborated by a working group of our network. Its diffusion will take place last quarter of 2016. The purpose of our study is to evaluate its usefulness through an observational multicenter before-after study, concerning every situation of brain dead patient where the next of kin are met by the medical staff. The refusal rate will be assessed over the first period (before the diffusion of the guide), from july 2012 to june 2014, and compared to that assessed over the second period (after the diffusion of the guide) from january 2017 to december 2018, using the national database of Biomedicine Agency. A comparison of this change in refusal rate will be made between centers of our network and the remaining centers in France nationwide. Anxiety of professionals will be assessed prospectively after each meeting conducted in one of our network centers, over 2 periods, before (from July to October 2016) and after (starting in january 2017) the diffusion of the dedicated guide for the conduct of the meeting with the next of kin. Compliance to the guide by the physicians and organ procurement nurses will be assessed after its diffusion in the centers of our network.


Recruitment information / eligibility

Status Completed
Enrollment 322
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- situation of confirmed brain dead patient, or dead patient with pending confirmation of brain death

Exclusion Criteria:

- situations where the next of kins are met before brain death

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Beaujon Clichy

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Refusal to organ procurement as expressed by next of kins Assessed in the national biomedicine agency database retrospectively over a 2-years period before diffusion of a dedicated guide for meeting, and prospectively over a 2 years period after the diffusion of a dedicated guide for meeting 2 years
Secondary Anxiety level of caregivers after meeting with the next of kins The anxiety will be measured by the short French version of the Spielberger anxiety state scale, and assessed prospectively over 2 periods, before and after the diffusion of a dedicated guide for meeting 2 years
Secondary Compliance to the guide The compliance will be measured though a debriefing form filled by the caregivers after each meeting with the next of kins 2 years
See also
  Status Clinical Trial Phase
Completed NCT03213171 - Promoting Organ Donor Registration in Family Physician Offices N/A
Completed NCT03816241 - Mechanisms of Nudges on Families' Decision-Making Process N/A
Completed NCT04007419 - Health Promoters and Organ Donation N/A
Completed NCT01969864 - University Student Intervention to Increase Organ Donation N/A
Completed NCT02836301 - RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education N/A
Completed NCT03612024 - Bernese Next of Kin Survey Following Organ Donation Request
Completed NCT03179020 - Donation Network to Optimize Organ Recovery Study N/A
Recruiting NCT05660252 - Effect of Collaborative Requesting on DCD Refusal Rates: Randomized Controlled Trial N/A
Terminated NCT03439995 - Goal of Open Lung Ventilation in Donors N/A
Completed NCT02525510 - Deceased Organ Donor Interventions to Protect Kidney Graft Function N/A
Completed NCT02138227 - A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation N/A
Recruiting NCT04661787 - Donation Advisor Clinical Decision Support Tool Study
Completed NCT02825862 - Investigating Affective Attitude Question-behaviour Effects on Intention to Become an Organ Donor N/A
Recruiting NCT03786991 - EPI-STORM: Cytokine Storm in Organ Donors
Active, not recruiting NCT03850847 - Understanding Decision Making in the Intensive Care Unit: a National Study
Recruiting NCT04734574 - Methods of Confirmation of Brain Death