Subarachnoid Hemorrhage of Aneurysmal CauseHSA RankinNCT06525012
Observational Study on Mortality and Outcome of Patients Hospitalized for Subarachnoid Hemorrhage of Aneurysmal Origin in Martinique Between 2013 and 2021
An observational study of Subarachnoid Hemorrhage of Aneurysmal Cause, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage of Aneurysmal Cause
- What is being tested?
- Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin
- How many people
- 122 participants
- Where
- 1 siteMartinique
- Study dates
- 19 Jul 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in Martinique for subarachnoid hemorrhage of aneurysmal origin
Who may be able to join
- 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.
Who cannot join
- Other causes of subarachnoid hemorrhage of non-aneurysmal origin (traumatic, arteriovenous malformation, cerebral tumor, cerebral thrombophlebitis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pauline PICHOIS contact
Martinique1 site, 1 recruiting
- Recruiting
University Hospital Center of Martinique
Fort-de-France, 97261
Yann MOPSUS, MSc, 0596553584, yann.mopsus@chu-martinique.fr
Marie SABIA, PhD
About this study
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.
Read the 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.
- Being tested
- Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin
- Keywords
- SAH (Subarachnoid Hemorrhage), Ruptured intracranial aneurysm, Modified Rankin score, Mortality, Patient autonomy, Patient dependence
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal originOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SAH of aneurysmal origin in hospitalized patients in Martinique between 2013 and 2021 | Not described Receives: Other: Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal origin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate mortality in patients hospitalized for subarachnoid hemorrhage of aneurysmal origin over a 9-year period (2013-2021) in Martinique.
Mortality of subarachnoid hemorrhage of aneurysmal origin.
Measured: 6 months
Secondary outcomes (4)
Evaluate the clinical outcome of these patients.
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).
Measured: 6 months
Analyze the factors associated with a significant impairment of autonomy and/or dependence.
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
Measured: 6 months
Analyze the factors associated with death.
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.
Measured: 6 months
Analyze the factors associated with a poor prognosis (death AND/OR significant impairment of autonomy/dependence).
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start19 Jul 2024
- Primary completion31 Dec 2024
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage of Aneurysmal CauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525012
- Sponsor's protocol ID
- 24_RIPH3-01
- Acronym
- HSA Rankin
- Status last verified
- Mar 2025
- First submitted
- 24 Jul 2024
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Mortality and Outcome of Patients Hospitalized for Subarachnoid Hemorrhage of Aneurysmal Origin in Martinique Between 2013 and 2021
- ClinicalTrials.gov ID
- NCT06525012
- Acronym / sponsor ID
- HSA Rankin / 24_RIPH3-01
- Keywords
- SAH (Subarachnoid Hemorrhage), Ruptured intracranial aneurysm, Modified Rankin score, Mortality, Patient autonomy, Patient dependence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Martinique for subarachnoid hemorrhage of aneurysmal origin
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Other causes of subarachnoid hemorrhage of non-aneurysmal origin (traumatic, arteriovenous malformation, cerebral tumor, cerebral thrombophlebitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual patient care for patients hospitalized for subarachnoid hemorrhage of aneurysmal originDuring 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. | Other | SAH of aneurysmal origin in hospitalized patients in Martinique between 2013 and 2021 |
Primary outcome
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.
4 secondary outcomes
Evaluate the clinical outcome of these patients.
Time frame: 6 months
Analyze the factors associated with a significant impairment of autonomy and/or dependence.
Time frame: 6 months
Analyze the factors associated with death.
Time frame: 6 months
Analyze the factors associated with a poor prognosis (death AND/OR significant impairment of autonomy/dependence).
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pauline PICHOIS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage of Aneurysmal Cause, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie SABIA, PhD (0596551054 ext. +596, marie.sabia@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate mortality in patients hospitalized for subarachnoid hemorrhage of aneurysmal origin over a 9-year period (2013-2021) in Martinique. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2025.