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OpenTrials
Completed

NCT Number: NCT06375889

Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital, Bron, Auvergne-Rhône-Alpes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: APICRASH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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