Thrombolysis Or Anticoagulation for Cerebral venous Thrombosis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

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.

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome on the modified Rankin Scale (mortality included) at 12 months after<br /><br>randomization is considered as the primary study outcome to determine the<br /><br>efficacy of thrombolytic treatment. For the primary endpoint the mRS will be<br /><br>dichotomized between 1 and 2 (i.e. poor outcome is defined as a score of 2 or<br /><br>higher, including death).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>- mRS at 6 months<br /><br>- Recanalization at 6 months using MR-venography or CT venography<br /><br>- Mortality at 6 months<br /><br>- Need for surgical intervention in relation to CVT (e.g. craniotomy)<br /><br><br /><br>Safety endpoints<br /><br>- Safety of endovascular thrombolysis as defined by major extracranial<br /><br>hemorrhagic com-plications and symptomatic intracranial hemorrhagic<br /><br>complications within one week fol-lowing the intervention.<br /><br>- All other serious adverse events</p><br>