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

Stress Disorders, Post-Traumatic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01214018
• Other study ID #: LOCAL/2009/CB-04
• Status: Terminated
• Phase: N/A
• First received: October 1, 2010
• Last updated: January 2, 2018
• Start date: May 15, 2011
• Est. completion date: May 15, 2016

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: May 15, 2016
• Est. primary completion date: May 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Stress Disorders, Post-Traumatic
• Tissue and Organ Procurement
• Tissue Donors

Intervention

Other:
• Questionnaires and interview
Questionnaires and interview

Locations

Country	Name	City	State
France	CH Henry Duffaut	Avignon
France	Centre Hospitalier Général	Beziers
France	Hôpital Guy de Chauliac, CHU de Montpellier	Montpellier Cedex 05
France	Centre Hospitalier Universitaire de Nîmes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with an IES score > 37	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	2 hours
Secondary	The IES score	The Impact of Event Scale - revised, ranging from 0 to 88	2 hours
Secondary	Hospital Depression and Anxiety Score (HDAS)	score ranging from 0 (no symptoms) to 21 (max). HDAS scores >=8 indicate clinically significant depression or axiety	2 hours