Observational Study on Mortality and Outcome of Patients Hospitalized for Subarachnoid Hemorrhage of Aneurysmal Origin in Martinique Between 2013 and 2021 (HSA Rankin)

March 26, 2025 updated by: University Hospital Center of Martinique
The aim of our study is to analyze mortality and sequelae of subarachnoid hemorrhage of aneurysmal origin in hospitalized patients in Martinique. Predictive factors of poor prognosis will also be analyzed.

Study Overview

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

Observational

Enrollment (Estimated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Fort-de-France, Martinique, 97261
        • Recruiting
        • University Hospital Center of Martinique
        • Contact:
        • Contact:
          • Marie SABIA, PhD
        • Contact:
          • Pauline PICHOIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients hospitalized in Martinique for subarachnoid hemorrhage of aneurysmal origin

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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