The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 17, 2020
February 1, 2020
1 year
February 12, 2020
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Favorable clinical outcome
3 months after randomization
Recanalization rate of cerebral venous system
3 months after randomization
Required surgical intervention in relation to CVST
3 months after randomization
All cause mortality
3 months after randomization
Study Arms (2)
Batroxobin combined with low molecular weight heparin
EXPERIMENTALStandard treatment of Batroxobin combined with low molecular weight heparin.
Low-molecular-weight heparin therapy
OTHERLow-molecular-weight heparin combined with routine drug therapy.
Interventions
Standard treatment of Batroxobin combined with low molecular weight heparin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- No informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu Hospital, Captial Medical University
Beijing, 100053, China
Related 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: 10.1007/s11239-018-1718-y.
PMID: 30062617RESULTDing 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 Neurosci Ther. 2019 May;25(5):638-646. doi: 10.1111/cns.13093. Epub 2019 Jan 23.
PMID: 30675757RESULTYang 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.115.011369. Epub 2015 Dec 15.
PMID: 26670082RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of neurology
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2021
Study Completion
December 1, 2021
Last Updated
February 17, 2020
Record last verified: 2020-02