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临床试验/NCT02013635
NCT02013635已完成不适用

Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution

University Hospital, Rouen72 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
232
试验地点
72
主要终点
Evolution of thrombin generation parameters

研究概览

简要总结

Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence of 3 to 4 per million people. It occurs generally in young patients (mean age of occurrence = 40 years) and principally in young females (75%) generally in pregnancy or oral contraceptive use situations.

The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more than 30 days). The clinical presentation is highly variable and includes patients with only a mild headache, others with focal neurological deficits and a few with a dramatic syndrome and a coma. Moreover the evolution can be very different with unpredictable outcome: more often it is favorable with a low mortality rate, but in some cases it can be a worse course. The aim of this study is to evaluate the correlation of some biological markers: thrombin generation test and D-Dimers (marker of fibrin generation and degradation) with the type of onset or the wide spectrum of clinical presentations or the different modes of evolution.

All patients over 16 years ago may be included in the program when CVT diagnosis is proved by magnetic resonance angiography (MRA). For each included patient, there are four blood assays: the first just at the time of diagnosis and before the beginning of treatment, the second before the beginning of the oral anticoagulant treatment. The third assay is done in the third month at the time of a MRA. The last assay is made one month after the end of the anticoagulant treatment or in 12th month after the beginning of the disease if the treatment goes on.

For each sample, the investigators perform a thrombin generation test and a D-Dimers measurement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging

排除标准

  • 未提供

结局指标

主要结局

Evolution of thrombin generation parameters

时间窗: one year

Evolution from Baseline in thrombin generation parameters and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale)

Evolution of D Dimers concentration

时间窗: one year

Evolution from Baseline in D Dimers concentration and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale)

次要结局

  • Evolution of thrombin generation parameters after end of treatment(one year)
  • MR Imaging and Thrombin generation parameters(one year)
  • MR Imaging and D Dimers concentration(one year)
  • Evolution of D Dimers concentration after treatment(one year)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (72)

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