Stress Disorders, Post-TraumaticNCT01214018
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors
An observational study of Stress Disorders, Post-Traumatic and Tissue Donors, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Tissue Donors, Tissue and Organ Procurement
- What is being tested?
- Questionnaires and interview
- How many people
- 91 participants
- Where
- 4 sitesFrance
- Study dates
- 15 May 2011to 15 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants are the nearest relatives of brain-dead patients
Who may be able to join
- must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased
Who cannot join
- refusal to participate
- does not speak French
- deaf/mute
- adult, but under guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Henry Duffaut
Avignon, 84902
Centre Hospitalier Général
Béziers, 34525
Hôpital Guy de Chauliac, CHU de Montpellier
Montpellier, 34295
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
About this study
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
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.
- Being tested
- Questionnaires and interview
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and interviewOther
Questionnaires and interview
| Study group | Role | What they receive |
|---|---|---|
| Reference | Nearest relatives of brain-dead patients who donated organs Receives: Other: Questionnaires and interview | |
| Opposition | Nearest relatives of brain-dead patients opposed to organ donation Receives: 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 Receives: Other: Questionnaires and interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (2)
The IES score
The Impact of Event Scale - revised, ranging from 0 to 88
Measured: 2 hours
Hospital Depression and Anxiety Score (HDAS)
score ranging from 0 (no symptoms) to 21 (max). HDAS scores >=8 indicate clinically significant depression or axiety
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study start15 May 2011
- Primary completion15 May 2016
- Study completion15 May 2016
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Boutin, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214018
- Sponsor's protocol ID
- LOCAL/2009/CB-04
- Status last verified
- Jan 2018
- First submitted
- 1 Oct 2010
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01214018
- Acronym / sponsor ID
- LOCAL/2009/CB-04
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No recruitment
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 May 2011 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 15 May 2016 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference | – | Other: Questionnaires and interviewNearest relatives of brain-dead patients who donated organs |
| Opposition | – | Other: Questionnaires and interviewNearest relatives of brain-dead patients opposed to organ donation |
| Medical/Legal | – | Other: Questionnaires and interviewNearest relatives of brain-dead patients for whom organ donation was not an option because of medical or legal reasons |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants are the nearest relatives of brain-dead patients
Key inclusion criteria (1 listed)
- must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased
Key exclusion criteria (4 listed)
- refusal to participate
- does not speak French
- deaf/mute
- adult, but under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and interviewQuestionnaires and interview | Other | Medical/Legal, Opposition, Reference |
Primary outcome
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
2 secondary outcomes
The IES score
Time frame: 2 hours
Hospital Depression and Anxiety Score (HDAS)
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: No recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Boutin, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic and Tissue Donors, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with an IES score > 37 (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.