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临床试验/NCT03359434
NCT03359434
已完成
不适用

Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 455 人2018年12月5日

概览

阶段
不适用
干预措施
Clearsight device (Edwards) around the finger
疾病 / 适应症
Acute Stroke
发起方
Fondation Ophtalmologique Adolphe de Rothschild
入组人数
455
试验地点
2
主要终点
Occurence of intracranial hemorrhagic complications
状态
已完成
最后更新
23天前

概览

简要总结

A monocentric, non-randomized, prospective study in which each patient is his/her own control.

The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.

详细描述

Patients will be followed for 72 hours: * inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure. * within 24 hours after reperfusion: blood pressure measurements * at 24 hours: NIHSS score. * Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). * 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner

注册库
clinicaltrials.gov
开始日期
2018年12月5日
结束日期
2024年12月4日
最后更新
23天前
研究类型
Observational
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Patient aged 18 years or older
  • Treated for occlusion of the internal carotid arteries and/or proximal middle cerebral arteries (M1 and M2 segments), vertebral artery, and/or basilar artery
  • Affiliated with or beneficiary of a Social Security plan
  • Having received informed information about the study and having given consent to participate in the study

排除标准

  • Per-procedure hemorrhagic complications (before reperfusion is achieved)
  • Patient benefiting from legal protection measures
  • Pregnant or breastfeeding women

研究组 & 干预措施

Two measuring methods of blood pressure

干预措施: Clearsight device (Edwards) around the finger

Two measuring methods of blood pressure

干预措施: Intermittent blood pressure measurements with cuff.

结局指标

主要结局

Occurence of intracranial hemorrhagic complications

时间窗: 36 hours after baseline

number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading

研究点 (2)

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