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

NCT ID: NCT01214018

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-15

Study Completion Date

2016-05-15

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Reference

Nearest relatives of brain-dead patients who donated organs

Questionnaires and interview

Intervention Type OTHER

Questionnaires and interview

Opposition

Nearest relatives of brain-dead patients opposed to organ donation

Questionnaires and interview

Intervention Type OTHER

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

Questionnaires and interview

Intervention Type OTHER

Questionnaires and interview

Interventions

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Questionnaires and interview

Questionnaires and interview

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Boutin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CH Henry Duffaut

Avignon, , France

Site Status

Centre Hospitalier Général

Béziers, , France

Site Status

Hôpital Guy de Chauliac, CHU de Montpellier

Montpellier, , France

Site Status

Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2009/CB-04

Identifier Type: -

Identifier Source: org_study_id

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