跳至主要内容
临床试验/NCT04971564
NCT04971564招募中不适用

Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia. A Case-control Trial Nested in a Cohort

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Biomarker rates at day 0

研究概览

简要总结

The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.

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

  • - For cases, admitted within the first 36 hours of an acute neurological symptom related to :
  • An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,
  • A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,
  • An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission >
  • For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score.
  • Express consent to participate in the study.
  • Member or beneficiary of a social security.

排除标准

  • Pre-existing functional and/or cognitive disability
  • Patient under legal protection.
  • Pregnant or breastfeeding woman.
  • Patient with secondary haemorrhagic transformation.
  • Secondary exclusion criteria :
  • Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy.
  • Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.).
  • TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.
  • Excluded patients will be replaced.

结局指标

主要结局

Biomarker rates at day 0

时间窗: 24 hours

Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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