BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time in therapeutic range
研究概览
简要总结
The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support.
The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care.
Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.
详细描述
Rationale:
Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome. The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO.
Hypothesis
Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin. Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin.
The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.
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
- •Patients receiving ECMO
- •Age: 18 years or older
- •Ability to randomise the patient within 4 hours of ECMO support initiation
排除标准
- •Post-cardiotomy ECMO patients
- •Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
- •Heparin induced thrombotic thrombocytopenia syndrome
- •Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
- •Limitations of care put in place either through patient wishes or the treating medical teams
- •Other reason where the treating physician deems the study is not in the patient's best interest
- •Patients who are suspected or confirmed to be pregnant
- •Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients
研究组 & 干预措施
Bivalirudin
Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds
干预措施: Bivalirudin (Drug)
Unfractionated Heparin
Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Time in therapeutic range
时间窗: 30 days
Proportion of monitoring samples within therapeutic range
次要结局
- Serious adverse events (SAEs)(30 days)
- Reasons for non-enrolment(30 days)
- Crossover between arms(30 days)
- Daily mean aPTT and anti-Xa(30 days)
- Enrolment rate(30 days)
- Protocol violations(30 days)
- Circuit changes(30 days)
- Thrombotic events(30 days)
- Bleeding events defined by Bleeding Academic Research Consortium (BARC)(30 days)
- Survival to Intensive care Unit (ICU) discharge(30 days)
- Survival to hospital discharge(30 days)
- Blood product usage(30 days)
- Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)(30 days)
- Cost(30 days)