Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 65,000
- 试验地点
- 9
- 主要终点
- 30-day all-cause mortality and bleeding requiring blood transfusion
研究概览
简要总结
DANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently used parenteral anticoagulants in Denmark, include the two different low molecular weight heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is a lack of evidence regarding whether these drugs are in fact comparable. The aim of this study is therefore to investigate the comparative safety and efficacy of the two different low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in patients with an indication for low molecular weight heparins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients with indication for low molecular weight heparin
排除标准
- •Patients under the age of 18
- •Patients who are incapable of understanding the written material received
- •Patients who after being informed in writing chooses not to participate
- •Patients with contraindications for low molecular weight heparins as described in the SmPC
研究组 & 干预措施
Dalteparin
干预措施: Tinzaparin profiled syringe (Drug)
Tinzaparin
干预措施: Dalteparin Prefilled Syringe (Drug)
结局指标
主要结局
30-day all-cause mortality and bleeding requiring blood transfusion
时间窗: 30 days
To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring blood transfusion during admission or death within 30 days in patients with indication for low molecular weight heparins.
次要结局
- Blood transfusion during admission(90 days)
- 90 day risk of pulmonary embolism(90 days)
- Length of hospital admission(Admission time (up to 1 year from inclusion measured in days))
- 30-day all-cause mortality(30 days)
- 365-day all-cause mortality(365 days)
- Heparin induced thrombocytopenia(90 days)
- 90 day risk of deep venous thrombosis(90 days)
- Liver failure(90 days)
- Days alive out of hospital(Time out of hospital (up to 1 year from inclusion measured in days))
研究者
Kasper Iversen
Clinical Professor
Herlev Hospital