Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Peak anti-Xa activity
研究概览
简要总结
Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients
详细描述
The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated
排除标准
- •renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy
- •liver cirrhosis
- •intravascular disseminated coagulation
- •contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,...)
- •patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)
研究组 & 干预措施
Intravenous group
干预措施: Nadroparin (intravenous Infusion) (Drug)
Subcutaneous group
干预措施: Nadroparin (subcutaneous group) (Drug)
结局指标
主要结局
Peak anti-Xa activity
时间窗: Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
次要结局
- AUC (0-24h)(0-24 hours)
- Trough anti-Xa activity(Trough anti-Xa activity measured 24 hours after start of low molecular weight administration)
研究者
Nicolas De Schryver
Principal investigator
Clinique Saint Pierre Ottignies