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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01214018
Enrollment
91
Registered
2010-10-04
Start date
2011-05-15
Completion date
2016-05-15
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

Questionnaires and interview

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants with an IES score > 372 hoursThe 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

MeasureTime frameDescription
The IES score2 hoursThe Impact of Event Scale - revised, ranging from 0 to 88
Hospital Depression and Anxiety Score (HDAS)2 hoursscore ranging from 0 (no symptoms) to 21 (max). HDAS scores \>=8 indicate clinically significant depression or axiety

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026