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

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ClinicalTrials.gov Identifier: NCT01214018
Recruitment Status : Terminated (No recruitment)
First Posted : October 4, 2010
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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
Stress Disorders, Post-Traumatic Tissue Donors Tissue and Organ Procurement Other: Questionnaires and interview

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
Primary Completion Date : May 15, 2016
Study Completion Date : May 15, 2016

Group/Cohort 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The IES score [ Time Frame: 2 hours ]
    The Impact of Event Scale - revised, ranging from 0 to 88

  2. Hospital Depression and Anxiety Score (HDAS) [ Time Frame: 2 hours ]
    score ranging from 0 (no symptoms) to 21 (max). HDAS scores >=8 indicate clinically significant depression or axiety



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants are the nearest relatives of brain-dead patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214018


Locations
France
CH Henry Duffaut
Avignon, France, 84902
Centre Hospitalier Général
Beziers, France, 34525
Hôpital Guy de Chauliac, CHU de Montpellier
Montpellier Cedex 05, France, 34295
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

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01214018     History of Changes
Other Study ID Numbers: LOCAL/2009/CB-04
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Brain Death
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes