跳至主要内容
临床试验/NCT06375889
NCT06375889已完成不适用

Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
4
主要终点
The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

aSAH group

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

干预措施: blood test (Other)

IPH group

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

干预措施: blood test (Other)

结局指标

主要结局

The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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