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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01214018
First received: October 1, 2010
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Proportion of participants with an IES score > 37 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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:
  • The IES score [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The Impact of Event Scale - revised, ranging from 0 to 88

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


Estimated Enrollment: 273
Study Start Date: May 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214018

Contacts
Contact: Caroline M Boutin, MD 33.4.66.68.30.50 caroline.boutinsada@orange.fr
Contact: Carey M Suehs, PhD 33.4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CH Henry Duffaut Recruiting
Avignon, France, 84902
Sub-Investigator: Karine Pavaday, MD         
Centre Hospitalier Général Recruiting
Beziers, France, 34525
Sub-Investigator: Olivier Jacquet Francillon, MD         
Hôpital Guy de Chauliac, CHU de Montpellier Recruiting
Montpellier Cedex 05, France, 34295
Sub-Investigator: Florence Vachiéry-Lahaye, MD         
Centre Hospitalier Universitaire de Nîmes Recruiting
Nimes, France, 30029
Contact: Caroline Boutin, MD    33.4.66.68.30.50    caroline.boutin@orange.fr   
Contact: Carey Suehs, PhD    33.4.66.68.67.88    carey.suehs@chu-nimes.fr   
Sub-Investigator: Laurent Muller, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Caroline Boutin, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01214018     History of Changes
Other Study ID Numbers: LOCAL/2009/CB-04
Study First Received: October 1, 2010
Last Updated: November 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014