The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis

Study Overview
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Brief Summary
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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 increase the neurological score of patients. Its main mechanism is to inhibit thrombosis after reducing fibrinogen, and to dissolve thrombus. To further explore the safety of batroxobin combined with anticoagulation therapy for CVST, an open-label, randomized controlled (1: 1), single-center, prospective study was used. Further study on the safety and effectiveness of batroxobin combined with anticoagulation for CVST.

Official Title
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The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis

Conditions
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Cerebral Venous Sinus Thrombosis, Batroxobin

Intervention / Treatment
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* Drug: Batroxobin combined with low molecular weight heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Batroxobin combined with low molecular weight heparin<br>Standard treatment of Batroxobin combined with low molecular weight heparin. | Drug: Batroxobin combined with low molecular weight heparin<br>* Standard treatment of Batroxobin combined with low molecular weight heparin<br>|
| Other: Low-molecular-weight heparin therapy<br>Low-molecular-weight heparin combined with routine drug therapy. | Drug: Batroxobin combined with low molecular weight heparin<br>* Standard treatment of Batroxobin combined with low molecular weight heparin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period |  | 2 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable clinical outcome | modified Rankin score 0-1 | 3 months after randomization | 
| Recanalization rate of cerebral venous system | DSA or MRV confirms cerebral venous sinus flow | 3 months after randomization | 
| Required surgical intervention in relation to CVST |  | 3 months after randomization | 
| All cause mortality |  | 3 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Venous Sinus Thrombosis