Batroxobin, Cerebral Venous Sinus Thrombosis
Conditions
Keywords
Cerebral Venous Sinus Thrombosis
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.
Interventions
DRUGBatroxobin combined with low molecular weight heparin
Standard treatment of Batroxobin combined with low molecular weight heparin
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Favorable clinical outcome | 3 months after randomization | modified Rankin score 0-1 |
| Recanalization rate of cerebral venous system | 3 months after randomization | DSA or MRV confirms cerebral venous sinus flow |
| Required surgical intervention in relation to CVST | 3 months after randomization | — |
| All cause mortality | 3 months after randomization | — |
Countries
China
Contacts
Primary ContactRan Meng, Ph.D
Backup ContactZhiying Chen, M.S.
Outcome results
None listed