Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-26 @ 1:31 PM
Study NCT ID:
NCT02854267
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2016-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANEVAS
Brief 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
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: