Cerebral Venous Sinus ThrombosisPhase 4NCT04269954
The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
A Phase 4 study testing Batroxobin combined with low molecular weight heparin in people with Cerebral Venous Sinus Thrombosis and Batroxobin, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Venous Sinus Thrombosis, Batroxobin
- What is being tested?
- Batroxobin combined with low molecular weight heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Captial Medical University
Beijing, 100053
Ran Meng, Ph.D, +86-10-83199280, ranmeng2011@pku.org.cn
Zhiying Chen, M.S., +86-10-83199280, chenzhiying@ccmu.edu.cn
About this study
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.
- Conditions
- Cerebral Venous Sinus Thrombosis, Batroxobin
- Being tested
- Batroxobin combined with low molecular weight heparin
- Keywords
- Cerebral Venous Sinus Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Batroxobin combined with low molecular weight heparinDrug
Standard treatment of Batroxobin combined with low molecular weight heparin
| Study group | Role | What they receive |
|---|---|---|
| Batroxobin combined with low molecular weight heparin | Experimental | Standard treatment of Batroxobin combined with low molecular weight heparin. Receives: Drug: Batroxobin combined with low molecular weight heparin |
| Low-molecular-weight heparin therapy | Other | Low-molecular-weight heparin combined with routine drug therapy. Receives: Drug: Batroxobin combined with low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period
Measured: 2 weeks after randomization
Secondary outcomes (4)
Favorable clinical outcome
modified Rankin score 0-1
Measured: 3 months after randomization
Recanalization rate of cerebral venous system
DSA or MRV confirms cerebral venous sinus flow
Measured: 3 months after randomization
Required surgical intervention in relation to CVST
Measured: 3 months after randomization
All cause mortality
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Venous Sinus ThrombosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Meng, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269954
- Sponsor's protocol ID
- CVST2020
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30062617Ding 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.
PubMed 30675757Yang 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.
PubMed 26670082
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
- ClinicalTrials.gov ID
- NCT04269954
- Acronym / sponsor ID
- CVST2020
- Conditions
- Cerebral Venous Sinus Thrombosis, Batroxobin
- Keywords
- Cerebral Venous Sinus Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Batroxobin combined with low molecular weight heparin | Experimental | Drug: Batroxobin combined with low molecular weight heparinStandard treatment of Batroxobin combined with low molecular weight heparin. |
| Low-molecular-weight heparin therapy | Other | Drug: Batroxobin combined with low molecular weight heparinLow-molecular-weight heparin combined with routine drug therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Batroxobin combined with low molecular weight heparinStandard treatment of Batroxobin combined with low molecular weight heparin | Drug | Batroxobin combined with low molecular weight heparin, Low-molecular-weight heparin therapy |
Primary outcome
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
4 secondary outcomes
Favorable clinical outcome
Time frame: 3 months after randomization
Recanalization rate of cerebral venous system
Time frame: 3 months after randomization
Required surgical intervention in relation to CVST
Time frame: 3 months after randomization
All cause mortality
Time frame: 3 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication: PubMed 30062617Ding 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 publication: PubMed 30675757Ding 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 publication: PubMed 26670082Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Batroxobin combined with low molecular weight heparin in people with Cerebral Venous Sinus Thrombosis and Batroxobin, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Meng, Ph.D (+86-10-83199280 ext. +861083199280, ranmeng2011@pku.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269954, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.