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

NCT01214018 | Terminated

• 1 other identifier: LOCAL/2009/CB-04
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The IES score

  2 hours

• Hospital Depression and Anxiety Score (HDAS)

  2 hours

Study Arms (3)

Reference

Nearest relatives of brain-dead patients who donated organs

Other: Questionnaires and interview

Opposition

Nearest relatives of brain-dead patients opposed to organ donation

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

Other: Questionnaires and interview

Interventions

Questionnaires and interview OTHER

Questionnaires and interview

Medical/Legal; Opposition; Reference

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants are the nearest relatives of brain-dead patients

You may qualify if:

• must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased

You may not qualify if:

• refusal to participate
• does not speak French
• deaf/mute
• adult, but under guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

CH Henry Duffaut

Avignon, 84902, France

Location

Centre Hospitalier Général

Béziers, 34525, France

Location

Hôpital Guy de Chauliac, CHU de Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Caroline Boutin, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: May 15, 2011
• Primary Completion: May 15, 2016
• Study Completion: May 15, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

FR (4)