Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors

Terminated

• Conditions: Stress Disorders, Post-Traumatic; Tissue Donors; Tissue and Organ Procurement
• Interventions: Other: Questionnaires and interview

• Registration Number: NCT01214018
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Study Start: 2011-05-15
• Primary Completion: 2016-05-15
• Study Completion: 2016-05-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased

Exclusion Criteria

• refusal to participate
• does not speak French
• deaf/mute
• adult, but under guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reference	Questionnaires and interview	Nearest relatives of brain-dead patients who donated organs
Medical/Legal	Questionnaires and interview	Nearest relatives of brain-dead patients for whom organ donation was not an option because of medical or legal reasons
Opposition	Questionnaires and interview	Nearest relatives of brain-dead patients opposed to organ donation

Primary Outcome Measures

Name	Time	Method
Proportion of participants with an IES score > 37	2 hours	The IES score follows Azoulay et al (2005). Am J Respir Crit Care Med. 171: 987-94. IES = Impact of Event Scale - revised, ranging from 0 to 88, with 88 being the greatest risk for post-traumatic stress

Secondary Outcome Measures

Name	Time	Method
The IES score	2 hours	The Impact of Event Scale - revised, ranging from 0 to 88
Hospital Depression and Anxiety Score (HDAS)	2 hours	score ranging from 0 (no symptoms) to 21 (max). HDAS scores \>=8 indicate clinically significant depression or axiety

Trial Locations

Locations (4)

CH Henry Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier Général; 🇫🇷 Beziers, France

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nimes, France

Hôpital Guy de Chauliac, CHU de Montpellier; 🇫🇷 Montpellier Cedex 05, France