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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01214018
Other study ID # LOCAL/2009/CB-04
Secondary ID
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
Health authority
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

Study Design


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
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