NCT00311753已完成3 期
An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment
研究概览
简要总结
Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.
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
- 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
- •Hospitalization due to an acute non-surgical disease
- •Significant decrease in mobility
排除标准
- •Indication for anticoagulant or thrombolytic therapy
- •Major surgical or invasive procedure within the 4 weeks that precede randomization
- •Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization
- •Immobilization due to cast or fracture of lower extremity
- •Immobilization lasting longer than 3 days in the period prior to randomization
- •Heparin administration longer than 36 hours in the period prior to randomization
- •Acute ischemic stroke
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
2
Active Comparator
Heparin
干预措施: Heparin (Drug)
1
Experimental
Certoparin
干预措施: Certoparin (Drug)
结局指标
主要结局
The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment
时间窗: 10 ± 2 days
次要结局
- Thromboembolic events during follow-up period of 3 months(90 days (± 7 days) after the end of the treatment)
- Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies(10 ± 2 days)
研究者
研究点 (1)
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