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

Cerebral Venous Sinus Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04269954
• Other study ID #: CVST2020
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2020
• Source: Capital Medical University
• Contact: Ran Meng, Ph.D
• Phone: +86-10-83199280
• Email: ranmeng2011[@]pku.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Batroxobin
• Cerebral Venous Sinus Thrombosis
• Sinus Thrombosis, Intracranial
• Thrombosis

Intervention

Drug:
• Batroxobin combined with low molecular weight heparin
Standard treatment of Batroxobin combined with low molecular weight heparin

Locations

Country	Name	City	State
China	Xuanwu Hospital, Captial Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Ding J, Zhou D, Hu Y, Elmadhoun O, Pan L, Ya J, Geng T, Wang Z, Ding Y, Ji X, Meng R. The efficacy and safety of Batroxobin in combination with anticoagulation on cerebral venous sinus thrombosis. J Thromb Thrombolysis. 2018 Oct;46(3):371-378. doi: 10.100 — View Citation

Ding JY, Pan LQ, Hu YY, Rajah GB, Zhou D, Bai CB, Ya JY, Wang ZA, Jin KX, Guan JW, Ding YC, Ji XM, Meng R. Batroxobin in combination with anticoagulation may promote venous sinus recanalization in cerebral venous thrombosis: A real-world experience. CNS N — View Citation

Yang Q, Duan J, Fan Z, Qu X, Xie Y, Nguyen C, Du X, Bi X, Li K, Ji X, Li D. Early Detection and Quantification of Cerebral Venous Thrombosis by Magnetic Resonance Black-Blood Thrombus Imaging. Stroke. 2016 Feb;47(2):404-9. doi: 10.1161/STROKEAHA.115.01136 — View Citation

Outcome

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