Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage (APICRASH)

January 26, 2026 updated by: Hospices Civils de Lyon

Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.

Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.

It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology.

Study Overview

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

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

Study Locations

    • Auvergne-Rhône-Alpes
      • Bron, Auvergne-Rhône-Alpes, France, 69005
        • Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital
    • Auvergnes-Rhones-Alpes
      • Bron, Auvergnes-Rhones-Alpes, France, 69005
        • Neurovascular intensive care unit department, Pierre Wertheimer hospital

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

We therefore chose to carry out an exhaustive recruitment of the active file of consecutive patients eligible for the study selection criteria. In the Medical ICA and Neurovascular ICU Department of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon, treating patients with sub-aneurysmal meningeal haemorrhage or intraparenchymal haemorrhage. 40 patients in each group

Description

Inclusion Criteria:

  • Male and Female Adults ≤18 years of age.
  • Hospitalised in the neurological intensive care unit of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon following an aneurysmal meningeal haemorrhage of any modified Fischer score, previously diagnosed by cerebral CT scan.
  • Patients admitted to the neurological intensive care unit or the NICU of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon for an intra-parenchymal haematoma.
  • Patient who has been informed and has formulated his/her non-opposition, or close relative of the patient who has been informed and has formulated his/her non-opposition.
  • Affiliated to a social security scheme.

Exclusion Criteria:

  • Non-aneurysmal SAH
  • Ischaemic stroke
  • Patients with previously known platelet function disorders
  • Pregnant or breast-feeding women
  • Patients under legal protection (guardianship, curatorship, safeguard of justice)
  • Patients under compulsory psychiatric care
  • Patients taking part in a study which may interfere with the present study

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
aSAH group
Patient hospitalised following the occurrence of an aneurysmal subarachnoid haemorrhage of any grade of severity.
During the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis
IPH group
Patient hospitalised following the occurrence of a non-traumatic intra-parenchymal haematoma.
During the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation.
Time Frame: Day of blood sample (inclusion visit) Day 3, day 5, day 7 and day 10 after inclusion visit

To describe the temporal kinetics of the percentage of activated platelets over time between patients with aHSA compared with the control group, consisting of patients with spontaneous intraparenchymal haematomas. Platelet cell activation is defined by the concomitant presence of the following markers: P-Selectin (CD-62); Gp Integrin Alpha IIb Beta 3 (CD-41); phosphatidylserine.

A mixed effects linear regression model will be used for data analysis.

Day of blood sample (inclusion visit) Day 3, day 5, day 7 and day 10 after inclusion visit

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Nicolas Chardon, MD;Msc, Intensive care department; Pierre Wertheimer Hospital

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)

June 14, 2024

Primary Completion (Actual)

January 24, 2026

Study Completion (Actual)

January 24, 2026

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

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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