Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage

NCT06375889 | Completed

• 2 other identifiers: 69HCL24_02502024-A00796-41
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Aneuvrysmal Subarachnoid Hemorrhage; Delayed Cerebral Ischemia; Endotheliopathy; Platelets Kinetic

Keywords

aSHA; DCI; Endotheliopathy; Platelets

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

aSAH group

Patient hospitalised following the occurrence of an aneurysmal subarachnoid haemorrhage of any grade of severity.

Other: blood test

IPH group

Patient hospitalised following the occurrence of a non-traumatic intra-parenchymal haematoma.

Other: blood test

Interventions

blood test OTHER

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; aSAH group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital

Bron, Auvergne-Rhône-Alpes, 69005, France

Location

Neurovascular intensive care unit department, Pierre Wertheimer hospital

Bron, Auvergnes-Rhones-Alpes, 69005, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2,7mL blood sample at day 0, 3, 5, 7, 10 (Total = 13,5mL) No other specimen required

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Nicolas Chardon, MD;Msc

  Intensive care department; Pierre Wertheimer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: June 14, 2024
• Primary Completion: January 24, 2026
• Study Completion: January 24, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

FR (2)