临床试验/NCT02902393

NCT02902393Unknown不适用

Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

University Hospital, Caen1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2016年7月最近更新: 2016年9月15日

适应症

试验速览

阶段: 不适用
发起方: University Hospital, Caen
入组人数: 64
试验地点: 1
主要终点: Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.

The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.

研究设计

研究类型: Observational
观察模型: Case Only
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 (> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).

排除标准

•Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).

结局指标

主要结局

Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI

时间窗: 24 hours

次要结局

Clinical evaluation using NIHSS scale(24 hours)

研究者

发起方

University Hospital, Caen

申办方类型

Other

责任方

Sponsor

研究点 (1)

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