Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
研究概览
简要总结
The primary purpose of this study is to demonstrate that a continuous infusion of intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that Intravenous administration is more effective.
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
- Double (Participant, Investigator)
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
- •Admission to the medical ICU (MICU)
- •High-risk for Venous Thromboembolism (VTE) ≥ 1 of the following:
- •Body Mass Index (BMI) ≥ 30 kg/m2
- •Personal or family history of VTE
- •Receiving vasopressors
排除标准
- •Indication for therapeutic anticoagulation
- •Evidence of deep vein thrombosis (DVT) on ultrasonography at admission
- •Indwelling intrathecal, epidural, or other indwelling deep catheters
- •Recent (< 3 months) International Society of Thrombosis and Haemostasis (ISTH) major bleeding13
- •Recent (< 3 months) major trauma
- •Recent (< 3 months) neurosurgery or orthopedic surgery Pregnancy
- •Contraindication to heparin or heparin products
研究组 & 干预措施
Intravenous continuous infusion of heparin (IV UFH)
Heparin will be administered intravenously.
干预措施: intravenous continuous infusion of heparin (IV UFH) (Drug)
Subcutaneous heparin
Heparin will be subcutaneously administered.
干预措施: Subcutaneous Heparin (Drug)
结局指标
主要结局
Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
时间窗: 3 Days
次要结局
未报告次要终点