Pronostic Factors in Elderly Patients Admitted to the Intensive Care Unit for Aneurysmal Subarachnoid Hemorrhage (FAPPAR-HSA)

March 31, 2026 updated by: ALB Ionel mircea, Central Hospital, Nancy, France

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ionel M ALB, MD Intensive Care/Anesthesia
  • Phone Number: 0033-661028367
  • Email: im.alb@chru-nancy.fr

Study Locations

  • France
      • Nancy, France, 54000
        • CHRU Nancy
        • Contact:
        • Principal Investigator:
          • Ionel M ALB, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients admitted in ICU for aneurysmal subarachnoid hemorrhage in 4 University Hospital Centers in France (CHU Nancy, CHU Reims, HC de Lyon, CHU Lille) between Juin 30, 2021 et Juin 30, 2025

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (MRS) et 6 months
Time Frame: 6 months after ICU discharge
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.
6 months after ICU discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intrahospital mortality
Time Frame: Day 28
Intrahospital mortality = percentage of deaths occuring during the initial hospitalisation (in the ICU and the neurosurgical/neurological ward)
Day 28
Cause of intrahospital death
Time Frame: Day 28
Percentage of the following categories: cerebral death, WOLST, surgical causes and medical causes
Day 28
Destination upon hospital discharge
Time Frame: Day 28
Percentage of the following categories: Discharge to Home versus Rehabilitation Unit versus Another Inpatient Ward (non-neurosurgical)
Day 28
Modified Rankin Scale upon discharge from hospital.
Time Frame: Day 28
MRS retrieved or estimated from patient's file data at the moment of ICU or neurosurgical ward discharge.
Day 28

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Viviane MARTIN, Chief of Research Departement, CHRU NANCY, DRCI
  • Study Chair: Elodie JEANBERT, Methodologist, Statistician, CHRU NANCY, DRCI

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025PI114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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