Thrombolysis Or Anticoagulation for Cerebral venous Thrombosis - TOACT

Academisch Medisch Centrum0 个研究点目标入组 38 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. CVT, confirmed by cerebral angiography (with intra-arte¬rial contrast injection), magnetic resonance venography or computed tomographic venography.
•2. Severe form of CVT with a high chance of poor outcome, as defined by the presence of one or more of the following risk factors
•a. Intracerebral hemorrhagic lesion due to CVT
•b. Mental status disorder
•c. Coma (Glasgow coma scale < 9)
•d. 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.

•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 inter¬fe¬res with nor¬mal coa¬gula¬tion
•* uncontrolled severe hypertension (diastolic > 120 mm Hg)
•* known recent (< 3 months) gastrointestinal tract hemorrhage (not including he¬morrhage from rectal hemorrhoids)
•Any known associated condition (such as terminal cancer) with a poor short term (1 year) prognosis inde¬pendent 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 proce¬dure (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

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