NCT02095509已完成4 期
Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Plasma anti-factor Xa level
研究概览
简要总结
To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily.
To investigate possible ongoing coagulation by coagulation markers during antithrombotic therapy with standard doses of enoxaparin
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index between 18-30 kg/m2
- •Critically ill patients requiring intensive care and pharmacological thromboprophylaxis
- •Expected to remain in the ICU for at least 72 h
- •Written informed consent obtained from the patient or his/her legal representative.
排除标准
- •Other indications for anticoagulant therapy than thromboprophylaxis
- •Intracranial haemorrhage or central neurosurgical operation within three months prior to the admission
- •Disseminated intravascular coagulation (DIC) according to the international society on Thrombosis and Haemostasis criteria
- •Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
- •Treatment with enoxaparin or any other low-molecular weight heparin (LMWH) or heparin within 24 hours prior to ICU admission. If patient has received thromboprophylactic dose of LMWH within 24-72 hours before ICU admission inclusion can be done if measured anti-factor Xa level is <0.1 IU/ml at the time of admission
- •Any long-term anticoagulant medication, expect low-dose aspirin
- •Major bleeding within the last week unless definitively treated
- •Blood platelet count <50, P-thromboplastin time (TT) <40% , international normalized ratio (INR) >1.7
- •Glomerular filtration rate less than 50 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation or chronic dialysis
- •HIV, hepatitis B virus, or hepatitis C virus infection
- •Pregnancy
研究组 & 干预措施
Subcutaneous Enoxaparin
Active Comparator
Subcutaneous enoxaparin 40 mg every 24 hours for three days
干预措施: Enoxaparin (Drug)
Intravenous Enoxaparin
Active Comparator
40 mg enoxaparin daily as continuous intravenous infusion for three days (72 hours)
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Plasma anti-factor Xa level
时间窗: 72 hours
Change in plasma anti-factor Xa levels between baseline and 72 hours
次要结局
- Incidence of Venous thromboembolism(90 days)
- Incidence of Bleeding(90 days)
研究者
研究点 (2)
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