Text Size

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

This study is currently recruiting participants.
Verified March 2013 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: March 22, 2013
Last verified: March 2013
History of Changes

October 1, 2010
March 22, 2013
May 2011
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01214018 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Study participants are the nearest relatives of brain-dead patients
  • Stress Disorders, Post-Traumatic
  • Tissue Donors
  • Tissue and Organ Procurement
Other: Questionnaires and interview
Questionnaires and interview
  • Reference
    Nearest relatives of brain-dead patients who donated organs
    Intervention: Other: Questionnaires and interview
  • Opposition
    Nearest relatives of brain-dead patients opposed to organ donation
    Intervention: 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
    Intervention: Other: Questionnaires and interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
273
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
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
France
 
NCT01214018
LOCAL/2009/CB-04
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Caroline Boutin, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP