Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin

Organ Donation Clinical Trial

— CANEVAS  

Official title:

Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854267
• Other study ID #: CANEVAS
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Organ Donation

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