Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 272
- 试验地点
- 23
- 主要终点
- Incidence of venous thromboembolism
研究概览
简要总结
To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy.
详细描述
This is a prospective, multi-center, randomized and controlled study. Advanced lung cancer patients without venous thromboembolism(VTE) are included. The selected patients were randomized into A and B groups. Group A: Nadroparin given during hospitalization, 0.4mL, subcutaneously, qid; Group B: Nadroparin given by long-term, 0.4mL, subcutaneously, qid. The incidence of VTE , the risks of bleeding and overall survival in two groups of patients are studied at different time points.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage Ⅲ B and Ⅳ non-small cell lung cancer patients and inoperable small cell lung cancer patients
- •Performance status score ≤ 2
- •Chest CT with measurable lesions
排除标准
- •Examination revealed any part of venous thromboembolism
- •Chemotherapy regimens containing bevacizumab or Endostar
- •Severe coagulopathy
- •Active bleeding within two weeks
研究组 & 干预措施
Long term prophylaxis
Nadroparin, 0.4mL, subcutaneously, qid, given by long-term
干预措施: Nadroparin, long term (Drug)
结局指标
主要结局
Incidence of venous thromboembolism
时间窗: 12 weeks
次要结局
- Incidence of bleeding(During 6 months)
研究者
Shengqing Li
Consultant, Associate professor
Air Force Military Medical University, China