NCT00328939已完成3 期
Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
研究概览
简要总结
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing either an elective major hip or knee replacement or revision.
- •Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.
排除标准
- •History of serious active bleeding in last 3 month
- •Concurrent or history of thrombocytopenia ( Platelet< 100x109/L)
- •History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
- •Acute bacterial endocarditis
- •Congenital or acquired bleeding disease in last 3 months
- •Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia
- •Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye
- •Conditions need to leave a tubule in intradural or extradural
- •Contraindication to anticoagulant or condition required to take long term oral anticoagulant
- •Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb
- •Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.
- •Concurrently to have hip and knee or double hip/knee replacement at the same time
结局指标
主要结局
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
次要结局
- Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
研究者
研究点 (7)
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