Status:
UNKNOWN
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
Lead Sponsor:
Capital Medical University
Conditions:
Cerebral Venous Sinus Thrombosis
Batroxobin
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Our previous clinical case observations showed that batroxobin combined with anticoagulation therapy can improve the sinus recanalization rate in patients with CVST, shorten the hospital stay, and inc...
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 CVST 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 CVST
- 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
- Conditions associated with increased risk of bleeding
- Any thrombolytic therapy within last 7 days
- Cerebellar venous thrombosis with 4th ventricle compression and hydrocephalus, which requires surgery
- Contraindication for anti-coagulant or batroxobin treatment 1)documented generalized bleeding disorder 2)concurrent thrombocytopenia (\<100 x 10E9/L) 3)Fibrinogen below 100mg /dl 4)documented severe hepatic or renal dysfunction, that interferes with normal coagulation 5)uncontrolled severe hypertension (diastolic \> 120 mm Hg) 6)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 CVST
- 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
- Previously legally incompetent prior to CVST
- Severe renal impairment
- Active liver disease
- Pregnancy, nursing or planning to become pregnant while in the trial
- Further exclusion criteria apply
- No informed consent.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04269954
Start Date
March 1 2020
End Date
December 1 2021
Last Update
February 17 2020
Active Locations (1)
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1
Xuanwu Hospital, Captial Medical University
Beijing, China, 100053