Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke (ROTEMPredict)
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Calvados
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Caen、Calvados、法国、14000
- 招聘中
- University Hospital
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接触：
- Christophe Kassel
- 电话号码：+33 0231063106
- 邮箱：directiongenerale@chu-caen.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
All patients meeting the eligibility criteria will be invited to participate in the study . Patients will be recruited to emergencies CHU Caen and Saint Joseph Hospital. The goal is to recruit patients with neurological defect consistent with a neurovascular pathology eligible for thrombolysis with tPA.
With the admission of patients, blood samples are routinely made . For this study, the investigators will add one citrated 5 mL tube. An information letter and consent form will be given to the patient.
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Success of revascularisation
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI
大体时间：24 hours
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24 hours
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Clinical evaluation using NIHSS scale
大体时间：24 hours
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24 hours
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合作者和调查者
调查人员
- 首席研究员：Richard MACREZ, PhD、University Hospital, Caen
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.