Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2)
试验速览
- 阶段
- 4 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percentage of time in the target anticoagulation range
研究概览
简要总结
This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.
详细描述
The investigators will randomly assign 34 adult patients requiring ECMO to receive bivalirudin or unfractionated heparin in a 1:1 fashion. There will be 17 patients in each group for a total of 34 patients.
Unfractionated heparin binds to antithrombin thereby causing an anticoagulant effect while bivalirudin binds directly to thrombin. Use of unfractionated heparin in this population is problematic due to reliance on adequate levels of circulating antithrombin, complex pharmacokinetics, and variable clearance. Bivalirudin avoids many of these difficulties.
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
- •Age ≥18 years
- •Require ECMO and systemic anticoagulation as determined by the primary treating physician
- •Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds
排除标准
- •Prior inclusion in this study
- •Patients with known or suspected heparin induced thrombocytopenia
- •Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
- •Allergy to heparin or related products or bivalirudin
- •Known anti-thrombin deficiency
- •Selection of a non-standard aPTT target range
研究组 & 干预措施
Unfractionated heparin
Patients randomized to this group will receive anticoagulation with unfractionated heparin
干预措施: Unfractionated heparin (Drug)
Bivalirudin
Patients randomized to this group will receive anticoagulation with bivalirudin
干预措施: Bivalirudin (Drug)
结局指标
主要结局
Percentage of time in the target anticoagulation range
时间窗: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
activated partial thromboplastin time
次要结局
- Major clinical thrombotic events(From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks)
- Duration of oxygenator use(From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks)
- Major bleeding events(From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks)
研究者
R. Brigg Turner
Principal investigator
Legacy Health System