EUCTR2015-005090-20-IT进行中（未招募）1 期
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study. THE PRO-LAPS STUDY II - The PROLAPS II Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 646
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 446
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
研究者
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