NCT03055026已完成3 期
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.
Fadoi Foundation, Italy17 个研究点 分布在 1 个国家目标入组 582 人开始时间: 2017年5月3日最近更新:
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
- 入组人数
- 582
- 试验地点
- 17
- 主要终点
- Venous thromboembolism
研究概览
简要总结
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objective diagnosis of colorectal cancer;
- •Elective laparoscopic surgery for colorectal cancer
- •Whatever the stage of cancer
- •Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery
排除标准
- •Age < 18 years
- •Surgery for non-cancer disease
- •Duration of surgery < 45 min
- •Conversion to open surgery
- •Other indication for anticoagulant therapy
- •Known cerebral metastases
- •Kidney or liver failure
- •Known hemorrhagic diathesis or high risk for bleeding
- •History of intracerebral bleeding or neurosurgery within 6 months
- •History of heparin induced thrombocytopenia
- •Pregnancy or lactation
- •Refusal of informed consent.
研究组 & 干预措施
Rivaroxaban
Experimental
Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)
干预措施: Rivaroxaban (Drug)
Placebo
Placebo Comparator
Orally administered, OD for 3 weeks (extended prophylaxis)
干预措施: Placebo (Drug)
结局指标
主要结局
Venous thromboembolism
时间窗: 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.
The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.
次要结局
未报告次要终点
研究者
研究点 (17)
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