- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06525012
Observational Study on Mortality and Outcome of Patients Hospitalized for Subarachnoid Hemorrhage of Aneurysmal Origin in Martinique Between 2013 and 2021 (HSA Rankin)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subarachnoid hemorrhage is an uncommon pathology in the general population, with a worldwide incidence of 9 per 100,000 people/year, but with a non-negligible risk of sequelae in terms of impairments, activity limitations and participation restrictions of around 30%. Mortality remains high at 40%, despite increasingly specialized care.
In addition, there are a number of objective, rapid assessment scores for autonomy and impairments, notably the modified Rankin score, which is not specific to subarachnoid hemorrhage, but which enables the study of patients' perceived quality of life. Certain factors predictive of bad patient outcome are known in the literature, but have been little studied in the population of Martinique.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie SABIA, PhD
- Phone Number: +596 0596551054
- Email: marie.sabia@chu-martinique.fr
Study Contact Backup
- Name: Pauline PICHOIS
- Email: paulinep13@live.fr
Study Locations
-
-
-
Fort-de-France, Martinique, 97261
- Recruiting
- University Hospital Center of Martinique
-
Contact:
- Yann MOPSUS, MSc
- Phone Number: 0596553584
- Email: yann.mopsus@chu-martinique.fr
-
Contact:
- Marie SABIA, PhD
-
Contact:
- Pauline PICHOIS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (≥18 years) patients,
- Admitted to University Hospital of Martinique with subarachnoid hemorrhage of aneurysmal origin between 01/01/2013 and 31/12/2021,
- Informed patient/next-of-kin/treating physician consent for research participation.
Exclusion Criteria:
- Other causes of subarachnoid hemorrhage of non-aneurysmal origin (traumatic, arteriovenous malformation, cerebral tumor, cerebral thrombophlebitis).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SAH of aneurysmal origin in hospitalized patients in Martinique between 2013 and 2021
|
Other: Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin
During hospitalization (2013-2021), patients were managed after multidisciplinary consultation in accordance with national recommendations between resuscitators, neurosurgeons and neuroradiologists, depending on the severity of the initial management and the patient's comorbidities, either by interventional radiology, neurosurgery or medical treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate mortality in patients hospitalized for subarachnoid hemorrhage of aneurysmal origin over a 9-year period (2013-2021) in Martinique.
Time Frame: 6 months
|
Mortality of subarachnoid hemorrhage of aneurysmal origin.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the clinical outcome of these patients.
Time Frame: 6 months
|
Patient's clinical outcome (mortality, impairment of patient autonomy, impairment of patient's level of dependece), assessed with the modified Rankin score at discharge and at a distance from hospitalization (minimum delay: 2.5 years).
|
6 months
|
|
Analyze the factors associated with a significant impairment of autonomy and/or dependence.
Time Frame: 6 months
|
Predictive factors associated with significant impairment of patient autonomy and/or dependence (modified Rankin score = 4 or 5): age, degree of consciousness at the time of treatment (WFNS score), amount of blood in the meningeal spaces (Fisher score), aneurysm size
|
6 months
|
|
Analyze the factors associated with death.
Time Frame: 6 months
|
Predictive factors associated with death (modified Rankin score = 6): age, degree of consciousness at the time of treatment (WFNS score), amount of blood in the meningeal spaces (Fisher score), aneurysm size.
|
6 months
|
|
Analyze the factors associated with a poor prognosis (death AND/OR significant impairment of autonomy/dependence).
Time Frame: 6 months
|
Predictive factors associated with a poor prognosis (modified Rankin score ≥ 4: death AND/OR impaired patient autonomy and/or dependence): age, degree of consciousness at the time of treatment (WFNS score), amount of blood in the meningeal spaces (Fisher score), aneurysm size.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24_RIPH3-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subarachnoid Hemorrhage of Aneurysmal Cause
-
The George InstituteTianjin Medical University General HospitalNot yet recruitingSubarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Hemorrhage, Aneurysmal SubarachnoidChina
-
Beijing Tiantan HospitalTianjin Medical University General Hospital; Development Center for Medical...Not yet recruitingAneurysmal Subarachnoid Hemorrhage | Aneurysmal Subarachnoid Hemorrhage (aSAH)China
-
Medical University InnsbruckRecruitingSubarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralAustria
-
Central Hospital, Nancy, FranceNot yet recruitingSubarachnoid Hemorrhage, AneurysmalFrance
-
Dr David Hasan, M.D.National Institute of Neurological Disorders and Stroke (NINDS); National Institutes...Not yet recruitingAneurysmal Subarachnoid HemorrhageUnited States
-
Beijing Tiantan HospitalNot yet recruitingAneurysmal Subarachnoid HemorrhageChina
-
Centre Hospitalier St AnneNot yet recruitingAneurysmal Subarachnoid Hemorrhage
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingSubarachnoid Hemorrhage, Aneurysmal | Subarachnoid Hemorrhage, SpontaneousItaly
-
El Instituto Nacional de Neurologia y Neurocirugia...CompletedBrain Ischemia | Subarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Delayed Cerebral Ischemia | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralMexico
-
Xiaolin Chen, MDPeking Union Medical CollegeRecruitingAneurysmal Subarachnoid HemorrhageChina
Clinical Trials on Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin
-
Sidekick HealthUniversity of Iceland; Landspitali University Hospital; Icelandic Research CenterRecruiting
-
EMİNE İNALCompletedHemodialysis | Anxiety | Psychological Well-BeingTurkey (Türkiye)
-
Baylor College of MedicineM.D. Anderson Cancer Center; Michael E. DeBakey VA Medical Center; Agency for...CompletedHypertension | Diabetes
-
Kaiser PermanenteCompleted
-
University of Alabama at BirminghamNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsRecruitingAutoimmune Diseases | Rheumatologic DiseaseUnited States
-
Jiawei JiangRecruitingClinical Decision Support SystemChina
-
Shiwen HongSir Run Run Shaw HospitalNot yet recruiting
-
Washington University School of MedicineTerminated
-
Karolinska InstitutetRegion StockholmRecruitingAnger | Aggression | Child Behavior Problem | Oppositional Defiant Disorder | Disruptive Behavior | Conduct ProblemsSweden
-
McMaster UniversityCompleted