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

Phase 4

• Conditions: Cerebral Venous Sinus Thrombosis; Batroxobin
• Interventions: Drug: Batroxobin combined with low molecular weight heparin

• Registration Number: NCT04269954
• Lead Sponsor: Capital Medical University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17
• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 CVST 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 CVST
   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

1. Conditions associated with increased risk of bleeding
2. Any thrombolytic therapy within last 7 days
3. Cerebellar venous thrombosis with 4th ventricle compression and hydrocephalus, which requires surgery
4. 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)
5. Any known associated condition (such as terminal cancer) with a poor short term (1 year) prognosis independent of CVST
6. Clinical and radiological signs of impending transtentorial herniation due to large space-occupying lesions (e.g. large cerebral venous infarcts or hemorrhages)
7. Recent (< 2 weeks) major surgical procedure (does not include lumbar puncture) or severe cranial trauma
8. Previously legally incompetent prior to CVST
9. Severe renal impairment
10. Active liver disease
11. Pregnancy, nursing or planning to become pregnant while in the trial
12. Further exclusion criteria apply
13. No informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Batroxobin combined with low molecular weight heparin	Batroxobin combined with low molecular weight heparin	Standard treatment of Batroxobin combined with low molecular weight heparin.
Low-molecular-weight heparin therapy	Batroxobin combined with low molecular weight heparin	Low-molecular-weight heparin combined with routine drug therapy.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Xuanwu Hospital, Captial Medical University; 🇨🇳 Beijing, China