- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508683
Pronostic Factors in Elderly Patients Admitted to the Intensive Care Unit for Aneurysmal Subarachnoid Hemorrhage (FAPPAR-HSA)
Pronostic Factors in Elderly Patients Admitted to the Intensive Care Unit for Aneurysmal Subarachnoid Hemorrhage Multicenter Retrospective Observational Study FAPPAR-HSA
Subarachnoid hemorrhage (SAH) represents a significant proportion of hemorrhagic strokes. Severe SAH in elderly patients is associated with poorer outcomes compared to younger cohorts. Better characterization of both short- and long -term prognosis in these patients is necessary to facilitate medical decision-making in the intensive care unit (ICU)
Primary Objective:
The primary objective is to identify prognostic factors associated with poor functional outcome or death at 6 months (± 2 months) in elderly patients admitted to the ICU for SAH.
Secondary Objectives:
To evaluate in-hospital mortality among elderly patients admitted to the ICU for SAH.
To describe the causes of in-hospital death (brain death, withholding/withdrawal of life-sustaining treatment [WOLST], other medico-surgical causes) in elderly patients admitted to the ICU for SAH.
To describe the care trajectory following hospital discharge for elderly patients admitted to the ICU for SAH.
To evaluate the mean length of stay in the ICU and in the hospital (acute care) for elderly patients admitted to the ICU for SAH.
To identify prognostic factors associated with poor functional outcome or death at 1 year in elderly patients admitted to the ICU for SAH.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ionel M ALB, MD Intensive Care/Anesthesia
- Phone Number: 0033-661028367
- Email: im.alb@chru-nancy.fr
Study Locations
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Nancy, France, 54000
- CHRU Nancy
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Contact:
- Ionel M ALB, MD
- Phone Number: 0033-661028367
- Email: im.alb@chru-nancy.fr
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Principal Investigator:
- Ionel M ALB, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients hospitalized in ICU for aneurysmal subarachnoid hemorrhage
- Aged 70 years or over the day of admission in ICU
- Between Juin 30, 2021 and Juin 30, 2025
Exclusion Criteria:
- Decline to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Elderly aneurysmal SAH patients hospitalized in ICU
Patients hospitalized in ICU for aneurysmal subarachnoid hemorrhage between Juin 30, 2021 and Juin 30, 2025.
Aged 70 years or over the day of admission in ICU.
In accordance with French regulations , the study included patients who did not object to the use of their clinical data after receiving written information.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Rankin Scale (MRS) et 6 months
Time Frame: 6 months after ICU discharge
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MRS : scale from 1(no symptoms) to 6 (dead) Good outcome : 0 - 2 Bad outcome: 3 - 6 The MRS grade is either collected if already available in the medical file or estimated retrospectively based on the patient neurological evaluation.
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6 months after ICU discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intrahospital mortality
Time Frame: Day 28
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Intrahospital mortality = percentage of deaths occuring during the initial hospitalisation (in the ICU and the neurosurgical/neurological ward)
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Day 28
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Cause of intrahospital death
Time Frame: Day 28
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Percentage of the following categories: cerebral death, WOLST, surgical causes and medical causes
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Day 28
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Destination upon hospital discharge
Time Frame: Day 28
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Percentage of the following categories: Discharge to Home versus Rehabilitation Unit versus Another Inpatient Ward (non-neurosurgical)
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Day 28
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Modified Rankin Scale upon discharge from hospital.
Time Frame: Day 28
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MRS retrieved or estimated from patient's file data at the moment of ICU or neurosurgical ward discharge.
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Day 28
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Viviane MARTIN, Chief of Research Departement, CHRU NANCY, DRCI
- Study Chair: Elodie JEANBERT, Methodologist, Statistician, CHRU NANCY, DRCI
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025PI114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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