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NCT Number: NCT06525012

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

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.

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Key information

Conditions

Subarachnoid Hemorrhage of Aneurysmal Cause Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Center of Martinique

Fort-de-France, 97261, Martinique

Location status: Recruiting

Location contact

Marie SABIA, PhD

PRINCIPAL_INVESTIGATOR

Pauline PICHOIS

SUB_INVESTIGATOR

Yann MOPSUS, MSc

CONTACT

[email protected]

0596553584

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie SABIA, PhD

CONTACT

[email protected]

0596551054 ext. +596

Pauline PICHOIS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Acronym: HSA Rankin

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Mar 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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