Checklist

  1. Check the inclusion and exclusion criteria
  2. Informed Consent
  3. Randomize Patient
  4. Complete the Case Record Form
    1. Baseline
    2. 1 Month follow up
    3. 6 Months follow up
    4. 12 Months follow up
  5. Monitor adverse events (S)AE form


Inclusion Criteria

  1. CVT confirmed by cerebral angiography (with intra-arte­rial contrast injection), magnetic resonance venography or computed tomographic venography.
  2. Severe form of CVT with a high chance of incomplete recovery as defined by the presence of one or more of the following risk factors
    1. Intracerebral hemorrhagic lesion due to CVT
    2. Mental status disorder
    3. Coma (Glasgow coma scale < 9)
    4. Thrombosis of the deep cerebral venous system
  3. Uncertainty by the treating physician if endovascular thrombolytic treatment (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)
  • Cerebellar venous thrombosis with 4th ventricle compression and hydrocephalus, which requires surgery
  • 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 thrombolytic 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.

Patients currently included

0 6 7

Last patient included on 14/10/2016 at Academic Medical CenterThe Netherlands

 

Contact

Academic Medical Centre
Department of Neurology H2-218

PO Box 22700
1100 DE Amsterdam
The Netherlands 

tel.   +31 20 566 45 91
fax.   +31 20 566 93 74
mob. +31 61 333 69 82 (24/7)
mail. to-act@amc.nl