The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Batroxobin combined with low molecular weight heparin
Standard treatment of Batroxobin combined with low molecular weight heparin.
干预措施: Batroxobin combined with low molecular weight heparin (Drug)
Low-molecular-weight heparin therapy
Low-molecular-weight heparin combined with routine drug therapy.
干预措施: Batroxobin combined with low molecular weight heparin (Drug)
结局指标
主要结局
Percentage of Participants With Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period
时间窗: 2 weeks after randomization
次要结局
- Required surgical intervention in relation to CVST(3 months after randomization)
- Favorable clinical outcome(3 months after randomization)
- Recanalization rate of cerebral venous system(3 months after randomization)
- All cause mortality(3 months after randomization)
研究者
Ran Meng
Professor of neurology
Capital Medical University