cerebral venous and sinus thrombosis Cerebral venous thrombosis
Conditions
Interventions
Eligible patients who give their informed consent are randomized (1:1 ) to
receive either
- Investigational treatment: endovascular thrombolytic treatment
- Standard care: (continuation of) any ther
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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 ( 120 mm Hg) * known recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome on the modified Rankin Scale (mortality included) at 12 months after randomization is considered as the primary study outcome to determine the efficacy of thrombolytic treatment. For the primary endpoint the mRS will be dichotomized between 1 and 2 (i.e. poor outcome is defined as a score of 2 or higher, including death). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints - mRS at 6 months - Recanalization at 6 months using MR-venography or CT venography - Mortality at 6 months - Need for surgical intervention in relation to CVT (e.g. craniotomy) Safety endpoints - Safety of endovascular thrombolysis as defined by major extracranial hemorrhagic com-plications and symptomatic intracranial hemorrhagic complications within one week fol-lowing the intervention. - All other serious adverse events | — |
Countries
Netherlands
Outcome results
None listed