NCT03359434已完成不适用
Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke
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
- 455
- 试验地点
- 2
- 主要终点
- Occurence of intracranial hemorrhagic complications
研究概览
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
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 (Device)
Two measuring methods of blood pressure
干预措施: Intermittent blood pressure measurements with cuff. (Device)
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
次要结局
未报告次要终点
研究者
研究点 (2)
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