NCT00685958已完成3 期
Multicenter, Non-comparative, Open-label Study to Evaluate the Safety and Efficacy of Enoxaparin Sodium (RP54563) 20 mg Bid for 14 Days in Patients With Hip Fracture Surgery
适应症
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
- 54
- 试验地点
- 1
- 主要终点
- bleeding events
研究概览
简要总结
The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •femoral neck inside or outside fracture
排除标准
- •any major surgery on lower limbs within 3 months
- •clinical signs of deep vein thrombosis
- •use of non-steroidal anti-inflammatory drugs
- •severe hepatic disease or renal insufficiency
结局指标
主要结局
bleeding events
时间窗: 28 days
次要结局
- incidence of venous thromboembolism(28 days)
研究者
研究点 (1)
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