Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage

Delayed Cerebral Ischemia Clinical Trial

— APICRASH  

Official title:

Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375889
• Other study ID #: 69HCL24_0250
• Secondary ID: 2024-A00796-41
• Status: Recruiting
• Start date: June 14, 2024
• Est. completion date: July 14, 2025

Study information

• Verified date: June 2024
• Source: Hospices Civils de Lyon
• Contact: Nicolas Chardon, MD;Msc
• Phone: 683396245
• Email: nicolas.chardon[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 14, 2025
• Est. primary completion date: July 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Delayed Cerebral Ischemia
• Hemorrhage
• Ischemia
• Subarachnoid Hemorrhage

Intervention

Other:
• blood test
During the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis

Locations

Country	Name	City	State
France	Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital	Bron	Auvergne-Rhône-Alpes
France	Neurovascular intensive care unit department, Pierre Wertheimer hospital	Bron	Auvergnes-Rhones-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation.	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