Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-17 @ 3:56 AM
Study NCT ID:
NCT01214018
Status:
TERMINATED
Last Update Posted:
2018-01-03
First Post:
2010-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'whyStopped': 'No recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2010-10-01', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with an IES score > 37', 'timeFrame': '2 hours', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'The IES score', 'timeFrame': '2 hours', 'description': 'The Impact of Event Scale - revised, ranging from 0 to 88'}, {'measure': 'Hospital Depression and Anxiety Score (HDAS)', 'timeFrame': '2 hours', 'description': 'score ranging from 0 (no symptoms) to 21 (max). HDAS scores \\>=8 indicate clinically significant depression or axiety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress Disorders, Post-Traumatic', 'Tissue Donors', 'Tissue and Organ Procurement']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants are the nearest relatives of brain-dead patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased\n\nExclusion Criteria:\n\n* refusal to participate\n* does not speak French\n* deaf/mute\n* adult, but under guardianship'}, 'identificationModule': {'nctId': 'NCT01214018', 'briefTitle': 'Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LOCAL/2009/CB-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reference', 'description': 'Nearest relatives of brain-dead patients who donated organs', 'interventionNames': ['Other: Questionnaires and interview']}, {'label': 'Opposition', 'description': 'Nearest relatives of brain-dead patients opposed to organ donation', 'interventionNames': ['Other: Questionnaires and interview']}, {'label': 'Medical/Legal', 'description': 'Nearest relatives of brain-dead patients for whom organ donation was not an option because of medical or legal reasons', 'interventionNames': ['Other: Questionnaires and interview']}], 'interventions': [{'name': 'Questionnaires and interview', 'type': 'OTHER', 'description': 'Questionnaires and interview', 'armGroupLabels': ['Medical/Legal', 'Opposition', 'Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84902', 'city': 'Avignon', 'country': 'France', 'facility': 'CH Henry Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '34525', 'city': 'Béziers', 'country': 'France', 'facility': 'Centre Hospitalier Général', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Guy de Chauliac, CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Caroline Boutin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}