A Prospective, Single- Center, Phase IV, Interventional, Single Arm Trial for the Evaluation of Subcutaneous Recombinant Hirudin 15 mg (RB Variant) in Prophylaxis of Deep Vein Thrombosis (DVT) Post Major Orthopedic Operations
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- new onset symptomatic thrombosis
研究概览
简要总结
This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations
详细描述
Prospective, Single arm, single-center
Phase IV
100 Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.
Patients undergoing major orthopedic operations
For Events of Deep Vein Thrombosis (DVT) within 15 days post-op.) All of the patients underwent Routine bilateral compression Doppler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Body Weight >60 kg
- •Patients undergoing major orthopedic operations
- •Patients ready to sign informed consent form (ICF)
- •Patients should discontinue any agents that affect haemostasis prior to the study medication use unless strictly indicated. These agents include medications such as: anticoagulants, thrombolytics, non-steroidal anti- inflammatory agents (including Ketorolac tromethamine), preparations containing aspirin, systemic salicylates, ticlopidine, dextran 40, clopidogrel, other anti-platelet agents including glycoprotein IIb/IIIa antagonists or systemic glucocorticoids.
排除标准
- •Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician
- •Hypersensitivity to Hirudin or prior documented Allergy to its components
- •Pregnant or breast feeding
- •Hemorrhagic stroke in preceding 3 months
- •abnormal baseline coagulation characterized by an INR >1.4, obtained at the discretion of the treating clinician
- •Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve
- •Patients with a history of coagulation disorder
- •Treatment with concomitant anti-platelet agent other than aspirin 326 mg or more daily (Platelet count< 100X109 /dl)
- •Active bleeding
- •Subjects with a life expectancy less than 1 month
研究组 & 干预措施
r-Hirudin
Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.
干预措施: r-Hirudin (Drug)
结局指标
主要结局
new onset symptomatic thrombosis
时间窗: up to 15 days post operative
Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction.
次要结局
- Adverse events(up to 15 days post operative)
- Major bleeding(up to 12 hours after surgery)