CTRI/2009/091/000460已完成3 期
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery (SAVE HIP 2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- A composite of any VTE confirmed by a blinded Central
研究概览
简要总结
Trial will be conducted in 28 countries all over the world. The Indian target -35 patients Indian status. The First subject in India was enrolled on 10th September 2008
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Standard surgery for fracture of the upper third of the femur including femoral head and neck.
排除标准
- •Estimated time of injury/fracture > 24 hours before admission to hospital.
- •Any major orthopedic surgery in the 3 months prior to study start.
- •Multiple trauma affecting more than one organ system.
- •Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome.
- •Patients at high risk of bleeding.
- •Known allergy to heparin, or enoxaparin, or pork products.
结局指标
主要结局
A composite of any VTE confirmed by a blinded Central
时间窗: From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first
efficacy evaluation period.
时间窗: From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first
Independent Adjudication Committee (CIAC), and deaths from any cause reported during the
时间窗: From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first
次要结局
- Any proximal DVT, symptomatic(distal DVT, non fatal PE, and all cause deaths.)
研究者
研究点 (9)
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