A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban as Anticoagulant in Patients With Extracorporeal Membrane Oxygenation (ECMO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
研究概览
简要总结
This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.
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
- 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
- •Minimum Age 18 years
- •VV- or VA-ECMO therapy
- •Minimum of 24h planned ECMO-therapy
排除标准
- •History of Heparin-induced thrombocytopenia (HIT)
- •High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count <50G/l, congenital bleeding disorder)
- •Pregnancy
- •Severe Liver disease (SOFA score liver domain 4 points = Bilirubin >12mg/dl)
- •Postoperative admission
- •Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT >50 sec without anticoagulation).
研究组 & 干预措施
Argatroban
Continuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL
干预措施: Argatroban (Drug)
Unfractionated Heparin
Continuous infusion of Unfractionated Heparin to target an aPTT of 50-60 seconds and/or Anti-Xa level between 0.20 and 0.30 IU/ml and/or thrombin time >20sec.
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
时间窗: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism
次要结局
- study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO(From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days)
研究者
Thomas Staudinger
Prof., MD
Medical University of Vienna