EUCTR2010-020302-15-PT进行中（未招募）不适用
/A - TOACT
IMM - Instituto de Medicina Molecular0 个研究点目标入组 164 人开始时间: 2011年8月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. CVT, confirmed by cerebral angiography (with intra-arte¬rial contrast injection), magnetic resonance venography or computed tomograhy venography.
- •2. Severe form of CVT with a relatively high chance of poor outcome, as determined by the presence of one of the following disease characteristics: mental status disorder, coma, intracerebral hemorrhage or thrombosis of the deep cerebral venous system.
- •3. Uncertainty by the treating physician if ET or standard heparin therapy is the optimal therapy for the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age less than 18 years
- •Duration from diagnosis to randomization of more than 10 days
- •Recurrent CVT
- •Any thrombolytic therapy within last 7 days
- •Pregnancy (women in the puerperium may be included)
- •Isolated cavernous sinus thrombosis
- •Isolated intracranial hypertension (without focal neurological signs, with the exception of papilloedema and 6th cranial nerve palsy)
- •Contraindication for anti-coagulant or thrombolytic treatment
- •?documented generalized bleeding disorder
- •?concurrent thrombocytopenia (<100 x 10E9/L)
- •?documented severe hepatic or renal dysfunction, that interferes with normal coagulation
- •?uncontrolled severe hypertension (diastolic > 120 mm Hg)
- •?known recent (< 3 months) gastrointestinal tract hemorrhage (not including hemorrhage from rectal hemorrhoids)
- •Any known associated condition (such as terminal cancer) with a poor short term (1 year) prognosis independent of CVT
- •Clinical and radiological signs of impending transtentorial herniation due to large space-occupying lesions (e.g. large cerebral venous infarcts or hemorrhages)
- •Recent (< 2 weeks) major surgical procedure (does not include lumbar puncture) or severe cranial trauma
- •Known allergy against contrast fluid used during endovascular procedures or the throm-bolytic drug used in that particular centre
- •Previously legally incompetent prior to CVT
- •No informed consent
- •General notes on exclusion criteria:
- •1.Intracerebral hemorrhage, hemorrhagic infarction, or subarachnoid hemorrhage as a result of CVT is not an exclusion criterion for this study.
- •2.Initial treatment with heparin is not an exclusion criterion for this study. Patients who deteriorate while on heparin treatment may be included and randomized if they fulfill the criteria.
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