Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- thrombotic complications
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.
详细描述
Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥ 18 years old
- •Accept VA-ECMO or VV-ECMO
- •the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s.
- •sign the informed consent form
排除标准
- •previous history of allergy to heparin or bivalirudin
- •previous diagnosis of heparin-induced thrombocytopenia.
- •the pre-random ECMO assistance time is more than 48 hours.
- •pregnant female
- •have participated in this study before.
- •the researchers believe that there are other factors that are not suitable to participate in this study.
研究组 & 干预措施
bivalirudin group
If the creatinine clearance rate > 30ml/min, the initial dose of bivalirudin is 0.04mg/kg/h. If the creatinine clearance rate<30ml/min or the patients who have received renal replacement therapy (CRRT), the initial dose of bivalirudin is 0.02mg/kg/h, and the dose is adjusted according to APPT to maintain APTT at 40-60s. After bivalirudin started, APTT was checked every 4 hours. If APTT was in the target range twice in a row, it was re-examined every 12 hours.
干预措施: bivalirudin (Drug)
unfractionated heparin group
The initial dose of heparin was 8-12U/kg/h, and the dosage of heparin was adjusted according to the value of APTT. APTT was maintained at 40-60s, and APTT was reexamined every 4 hours.
干预措施: unfractionated heparin (Drug)
结局指标
主要结局
thrombotic complications
时间窗: Within seven days after starting anticoagulant therapy
main end point of efficacy
bleeding complications
时间窗: Within seven days after starting anticoagulant therapy
main safety endpoint
次要结局
- Percentage of time during ECMO within the target anticoagulant level(Within seven days after starting anticoagulant therapy)
- Infusion volume of blood products(Within seven days after starting anticoagulant therapy)
- Acute renal failure(Within seven days after starting anticoagulant therapy)
- Heparin-induced thrombocytopenia(Within seven days after starting anticoagulant therapy)
- the time of reaching the target anticoagulant level for the first time(Within seven days after starting anticoagulant therapy)
- Hospitalization mortality(28 days)
- Loop replacement(Within seven days after starting anticoagulant therapy)
研究者
Xiaotong Hou
Clinical professor
Beijing Anzhen Hospital