Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prothrombin fragment F1+2
研究概览
简要总结
The purpose of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.
详细描述
Hypotheses
- The intervention group of oesophageal cancer patients, who receive prolonged thromboprophylaxis with Fragmin® has a lower VTE risk, expressed by a lower prothrombin fragment F1+2, 30 days after surgery than the control group, who receive Fragmin® for 10 days.
- The intervention group does not demonstrate an increased bleeding tendency compared with the control group.
Primary endpoint The primary endpoint is the difference in prothrombin fragment F1+2 30 days after surgery between the intervention and the control group.
Secondary and safety endpoints The secondary endpoints are incidence of bleeding, VTE and mortality 30 days and one year after surgery.
Study design
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
盲法说明
No masking due to ethical considerations. Primary outcome is biochemical.
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
- •Cancer located in oesophagus and/or cardia.
- •Candidate for intended curative surgery.
- •Age > 18 years.
排除标准
- •Known inherited bleeding disorder.
- •Unable to provide informed consent.
- •Arterial or venous thromboembolic events within the last three months.
- •On-going anticoagulant treatment (Vitamin K antagonists or direct oral anticoagulants).
- •Pregnant or has given birth within the last three months.
- •Known allergy to the trial drug Dalteparin (Fragmin®).
研究组 & 干预措施
Intervention
Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily.
干预措施: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe (Drug)
Control
Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily.
干预措施: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe (Drug)
结局指标
主要结局
Prothrombin fragment F1+2
时间窗: 30 days after surgery.
Difference in prothrombin fragment F1+2 between the intervention and the control group.
次要结局
- Venous thromboembolic events(30 days and one year after surgery)
- Mortality(30 days and one year after surgery)
- Bleeding(30 days after surgery.)