- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06375889
Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage (APICRASH)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Auvergne-Rhône-Alpes
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Bron, Auvergne-Rhône-Alpes, France, 69005
- Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital
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Auvergnes-Rhones-Alpes
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Bron, Auvergnes-Rhones-Alpes, France, 69005
- Neurovascular intensive care unit department, Pierre Wertheimer hospital
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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:
- 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
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.
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During the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis
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IPH group
Patient hospitalised following the occurrence of a non-traumatic intra-parenchymal haematoma.
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During the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis
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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
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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
Sponsor
Investigators
- Principal Investigator: Nicolas Chardon, MD;Msc, Intensive care department; Pierre Wertheimer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Brain Infarction
- Infarction
- Necrosis
- Intracranial Hemorrhages
- Stroke
- Cerebral Infarction
- Ischemia
- Hemorrhage
- Subarachnoid Hemorrhage
- Brain Ischemia
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Hematologic Tests
Other Study ID Numbers
- 69HCL24_0250
- 2024-A00796-41 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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