NCT00723216已完成3 期
Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Venous thromboembolism incidence
研究概览
简要总结
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.
排除标准
- •surgery under laparoscope and other endoscopic operations
- •clinical signs of deep vein thrombosis
- •use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
- •severe hepatic disease or renal disease
- •women of childbearing potential, pregnant or lactating.
研究组 & 干预措施
1
Active Comparator
Enoxaparin
干预措施: enoxaparin (Drug)
2
Other
Intermittent Pneumatic Compression (IPC)
干预措施: Physical prophylaxis (Other)
结局指标
主要结局
Venous thromboembolism incidence
时间窗: 28 days
次要结局
- Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis(28 days)
研究者
研究点 (1)
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