Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Anti-Xa concentration maximum 0-24h (Cmax0-24h)
研究概览
简要总结
To evaluate the pharmacokinetics of thromboprophylactic doses of LMWH enoxaparin in postoperative CABG patients, drug is administered either as a continuous intravenous infusion (CIV) or subcutaneous bolus (SCB) once per 72h. Plasma anti-Xa values are measured 12-14 times during study period and concentration maximums calculated to enable comparison of anti-Xa values between administration routes.
详细描述
This is a prospective, randomized, controlled trial. After informed consent, 80 elective on pump CABG patients with a clinical indication for post-operative thromboprophylaxis will be studied in the Tampere University Heart Hospital. Study has two independent parts with 40 patients in both. Results are reported separately from these two parts of the study.
Firts part of the study: After written consent, 20+20 patients are randomized to receive enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus injection (control group). Enoxaparin dose is 40mg/24h either CIV of SCB. Anti-Xa values are measured 12-14 times from blood samples to evaluate the anticoagulation effect of enoxaparin.
Second part of the study: After written consent, 20+20 patients are randomized to receive enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus injection (control group). Enoxaparin dose is 1mg/kg/24h in CIV group and 0,5mg/kg twice a day in SCB group. In this second part of the study with eleveted enoxaparin dosage, 4 additional blood samples will be taken and analysed by ROTEM to investigate the overall coagulation status of the patients before and after the initiation of enoxaparin.
The study will consist of two independent parts.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 18-33 kg/m2
- •Elective on-pump CABG operation
- •Indication for post-operative pharmacological thromboprophylaxis
- •Written informed consent obtained from the patient or his/her legal representative.
排除标准
- •Other indications for anticoagulant therapy than thromboprophylaxis
- •Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
- •Any long-term anticoagulant medication, expect low-dose aspirin
- •Major bleeding within the last week unless definitively treated
- •Blood platelet count <20, P-TT <20 % or INR >1.7
- •GFR less than 30 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation 13 or chronic dialysis
- •Known HIV, HBV, or HCV infection
- •Pregnancy
研究组 & 干预措施
Enoxaparin 40 mg s.c.
Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours)
干预措施: Enoxaparin (Drug)
Enoxaparin 40 mg i.v.
Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours)
干预措施: Enoxaparin (Drug)
Enoxaparin 0.5 mg/kg s.c.
Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours)
干预措施: Enoxaparin (Drug)
Enoxaparin 1 mg/kg i.v.
Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours)
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Anti-Xa concentration maximum 0-24h (Cmax0-24h)
时间窗: 0-24h after initiation of enoxaparin
Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.
次要结局
- Anti-Xa concentration maximum 25-72 h (Cmax25-72h)(25-72 h after initiation of enoxaparin)
- Anti-Xa trough concentartion at 72 h (C72h)(72 h after the initiation of enoxaparin)