Status:
TERMINATED
Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis
Lead Sponsor:
Jan Stam, MD, PhD
Collaborating Sponsors:
Dutch Heart Foundation
Conditions:
Sinus Thrombosis, Intracranial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis...
Eligibility Criteria
Inclusion
- Cerebral venous thrombosis, confirmed by cerebral angiography (with intra-arterial contrast injection), magnetic resonance venography or computed tomographic venography.
- 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
- Intracerebral hemorrhagic lesion due to CVT
- Mental status disorder
- Coma (Glasgow coma scale \< 9)
- Thrombosis of the deep cerebral venous system
- Uncertainty by the treating physician if ET or standard heparin therapy is the optimal therapy for the patient.
Exclusion
- 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 he¬morrhage 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01204333
Start Date
September 1 2011
End Date
October 1 2017
Last Update
February 14 2017
Active Locations (15)
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1
Centre hospitalier de l'université de Montréal (CHUM)
Montreal, Canada
2
XuanWu Hospital
Beijing, China
3
Hôpital Lariboisière
Paris, France
4
Academic Medical Centre
Amsterdam, Netherlands