Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT01204333
Eligibility Criteria:
Inclusion Criteria:
1. Cerebral venous thrombosis, 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 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
1. documented generalized bleeding disorder
2. concurrent thrombocytopenia (\<100 x 10E9/L)
3. documented severe hepatic or renal dysfunction, that interferes with normal coagulation
4. uncontrolled severe hypertension (diastolic \> 120 mm Hg)
5. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01204333
Study Brief:
Protocol Section:
NCT01204333