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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Batroxobin combined with low molecular weight heparin | Experimental | Standard treatment of Batroxobin combined with low molecular weight heparin. |
|
| Low-molecular-weight heparin therapy | Other | Low-molecular-weight heparin combined with routine drug therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Batroxobin combined with low molecular weight heparin | Drug | Standard treatment of Batroxobin combined with low molecular weight heparin |
|
| 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 |
| 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 |
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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
Uncertainty by the treating physician if ET or standard heparin therapy is the optimal therapy for the patient.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ran Meng, Ph.D | Contact | +86-10-83199280 | +861083199280 | ranmeng2011@pku.org.cn |
| Zhiying Chen, M.S. | Contact | +86-10-83199280 | +861083199280 | chenzhiying@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Captial Medical University | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30062617 | Result | 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. | |
| 30675757 | Result | 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 Neurosci Ther. 2019 May;25(5):638-646. doi: 10.1111/cns.13093. Epub 2019 Jan 23. |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 3 months after randomization |
| Required surgical intervention in relation to CVST | 3 months after randomization |
| All cause mortality | 3 months after randomization |
| 26670082 | Result | 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.115.011369. Epub 2015 Dec 15. |