Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05016635
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2021-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability Adjusted Life Years', 'timeFrame': '9 years', 'description': 'Mortality and Morbidity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort']}, 'descriptionModule': {'briefSummary': 'Subarachnoid hemorrhage (SAH) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. There is a paucity of data on the burden of SAH in African countries. In this study, we analyzed data from patients in the largest neurovascular center in Senegal to determine the sex- and age-adjusted burden of SAH in Senegal.', 'detailedDescription': 'The Fann Teaching Hospital (Dakar, Senegal) institutional review board authorized this study. Consent was obtained from adult patients and the parents/legal guardians of children. Patient data were stored in a password-protected Excel spreadsheet, and this spreadsheet was stored on a hard drive. Only the authors had access to the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We recruited 448 patients between 2011 and 2020. However, 60 patients (13.4%) had incomplete records and were excluded from the analysis. Herein we present the retrospective analysis of the 388 patients (86.6%) with complete records. We received a median of 40.0 patients annually (IQR=51.5), and a peak was observed in 2017 when 76 SAH patients were admitted at our institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sub-arachnoid Hemorrhage admission\n\nExclusion Criteria:\n\n* Not admitted for sub-arachnoid hemorrhage'}, 'identificationModule': {'nctId': 'NCT05016635', 'briefTitle': 'Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Association of Future African Neurosurgeons, Yaounde, Cameroon'}, 'officialTitle': 'Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'AFANSEN1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sub-arachnoid Hemorrhage Patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dakar', 'country': 'Senegal', 'facility': 'Fann Teaching Hospital', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association of Future African Neurosurgeons, Yaounde, Cameroon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}