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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01214018
• Collaborator: (none)
• Enrollment: 91
• Locations: 4
• Actual Duration (Months): 60
• Patients Per Site: 22.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic; Tissue Donors; Tissue and Organ Procurement	Other: Questionnaires and interview

Study Design

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: May 15, 2011
• Actual Primary Completion Date: May 15, 2016
• Actual Study Completion Date: May 15, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. The IES score [2 hours]

   The Impact of Event Scale - revised, ranging from 0 to 88

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Henry Duffaut	Avignon		France	84902
2	Centre Hospitalier Général	Beziers		France	34525
3	Hôpital Guy de Chauliac, CHU de Montpellier	Montpellier Cedex 05		France	34295
4	Centre Hospitalier Universitaire de Nîmes	Nimes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Caroline Boutin, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01214018
• Other Study ID Numbers: LOCAL/2009/CB-04
• First Posted: Oct 4, 2010
• Last Update Posted: Jan 3, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Brain Death; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jan 3, 2018