Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition

Centre Hospitalier Universitaire de Nīmes4 sites in 1 country91 target enrollmentMay 15, 2011

ConditionsStress Disorders, Post-Traumatic Tissue Donors Tissue and Organ Procurement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stress Disorders, Post-Traumatic
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 91
Locations: 4
Primary Endpoint: Proportion of participants with an IES score > 37
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 15, 2011

End Date

May 15, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Proportion of participants with an IES score > 37

Time Frame: 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