Back to resultsThe Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
Primary Purpose
Cerebral Venous Sinus Thrombosis, Batroxobin
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Batroxobin combined with low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Venous Sinus Thrombosis focused on measuring Cerebral Venous Sinus Thrombosis
Eligibility Criteria
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.
Sites / Locations
- Xuanwu Hospital, Captial Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Batroxobin combined with low molecular weight heparin
Low-molecular-weight heparin therapy
Arm Description
Standard treatment of Batroxobin combined with low molecular weight heparin.
Low-molecular-weight heparin combined with routine drug therapy.
Outcomes
Primary Outcome Measures
Percentage of Participants With Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period
Secondary Outcome Measures
Favorable clinical outcome
modified Rankin score 0-1
Recanalization rate of cerebral venous system
DSA or MRV confirms cerebral venous sinus flow
Required surgical intervention in relation to CVST
All cause mortality
Full Information
NCT ID
NCT04269954
First Posted
February 12, 2020
Last Updated
February 12, 2020
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04269954
Brief Title
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
Official Title
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Venous Sinus Thrombosis, Batroxobin
Keywords
Cerebral Venous Sinus Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Batroxobin combined with low molecular weight heparin
Arm Type
Experimental
Arm Description
Standard treatment of Batroxobin combined with low molecular weight heparin.
Arm Title
Low-molecular-weight heparin therapy
Arm Type
Other
Arm Description
Low-molecular-weight heparin combined with routine drug therapy.
Intervention Type
Drug
Intervention Name(s)
Batroxobin combined with low molecular weight heparin
Intervention Description
Standard treatment of Batroxobin combined with low molecular weight heparin
Primary Outcome Measure Information:
Title
Percentage of Participants With Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period
Time Frame
2 weeks after randomization
Secondary Outcome Measure Information:
Title
Favorable clinical outcome
Description
modified Rankin score 0-1
Time Frame
3 months after randomization
Title
Recanalization rate of cerebral venous system
Description
DSA or MRV confirms cerebral venous sinus flow
Time Frame
3 months after randomization
Title
Required surgical intervention in relation to CVST
Time Frame
3 months after randomization
Title
All cause mortality
Time Frame
3 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Meng, Ph.D
Phone
+86-10-83199280
Ext
+861083199280
Email
ranmeng2011@pku.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiying Chen, M.S.
Phone
+86-10-83199280
Ext
+861083199280
Email
chenzhiying@ccmu.edu.cn
Facility Information:
Facility Name
Xuanwu Hospital, Captial Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Meng, Ph.D
Phone
+86-10-83199280
Email
ranmeng2011@pku.org.cn
First Name & Middle Initial & Last Name & Degree
Zhiying Chen, M.S.
Phone
+86-10-83199280
Email
chenzhiying@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhiying Chen
First Name & Middle Initial & Last Name & Degree
Jiayue Ding
First Name & Middle Initial & Last Name & Degree
Da Zhou
First Name & Middle Initial & Last Name & Degree
Chaobo Bai
First Name & Middle Initial & Last Name & Degree
Jingyuan Ya
First Name & Middle Initial & Last Name & Degree
Kexin Jin
First Name & Middle Initial & Last Name & Degree
Zhongao Wang
First Name & Middle Initial & Last Name & Degree
Jingwei Guan
First Name & Middle Initial & Last Name & Degree
Jingkun Sun
First Name & Middle Initial & Last Name & Degree
Siying Song
12. IPD Sharing Statement
Citations:
PubMed Identifier
30062617
Citation
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.
Results Reference
result
PubMed Identifier
30675757
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 Neurosci Ther. 2019 May;25(5):638-646. doi: 10.1111/cns.13093. Epub 2019 Jan 23.
Results Reference
result
PubMed Identifier
26670082
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.115.011369. Epub 2015 Dec 15. Erratum In: Stroke. 2016 Feb;47(2):e39.
Results Reference
result
Learn more about this trial
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
We'll reach out to this number within 24 hrs