A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of circuit failures requiring a circuit exchange
研究概览
简要总结
This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.
详细描述
This open label randomized study will compare the clinical outcomes of patients on ECMO who are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient time to randomize these frequently emergent patients. Consent for the study will be obtained from a legally authorized representative Prior to starting a continuous infusion of maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of cross-overs between the two research arms, circuit failures, decannulation, deaths and discharges from hospital.
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
- •Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO
排除标准
- •Patient or surrogate decision makers cannot provide informed consent.
- •Patients who have intolerance to either heparin or bivalirudin
- •Patients who received any form of thrombolytic therapy within the past 30 days.
研究组 & 干预措施
Bivalirudin Injection (Angiomax)
This arm will receive intravenous Bivalirudin for ECMO anticoagulation for the extent of ECMO support or 7 days whichever comes first
干预措施: Bivalirudin Injection [Angiomax] (Drug)
Heparin Sodium
This arm will receive intravenous Heparin Sodium for ECMO anticoagulation for the extent of ECMO support or 7 days whichever comes first
干预措施: Heparin Sodium (Drug)
结局指标
主要结局
Number of circuit failures requiring a circuit exchange
时间窗: 30 days
Will be determined by total number of circuit exchanges needed in ECMO circuit due to thrombosis. Circuit exchanges may be done due to lack of adequate gas exchange or increased resistance pre and post oxygenator \>50mmHg, circuit thrombosis or failure requiring emergent decannulation
Number of patients surviving to discharge
时间窗: 30 days
This will be assessed by the number of patients in each arm who survive to discharge
Bleeding events
时间窗: 30 days
Will be assessed by the total number of one or more of the following: Chest tube output of blood, number of take-backs to operating room for bleeding, number of Hemorrhagic strokes, Gastrointestinal bleeding, Retroperitoneal hemorrhage, number of cessations of anticoagulation for refractory bleeding and any use of antifibrinolytics or factor VII
Renal failure
时间窗: 30 days
Defined as initiation of renal replacement therapy for kidney injury that develops on ECMO or increase in serum creatinine by more than 2 times its baseline or decrease in Glomerular Filtration Rate by more than 50% or urine output less than 0.3 mL/kg/hr. We will determine the number of patients with renal failure
Thrombotic events
时间窗: 30 days
Collect number of thrombotic events, defined as any of the following events; embolic strokes, embolic end-organ ischemia, embolic ischemia to limbs, deep vein thrombosis or venous thromboembolism, Oxygenator effectiveness measured by resistance, Alveolar-arterial oxygen gradient and carbon dioxide elimination
Number of Transfusions
时间窗: 30 days
This will be assessed by any of the following: number of utilizations of packed red blood cells and utilization of fresh frozen plasma, utilization of platelets, utilization of cryoprecipitate, utilization of anti-thrombin III, utilization of factor VII, utilization of prothrombin complex concentrate
Number of emergent decannulations
时间窗: 30 days
This will be assessed by the number of times patient is separated from ECMO
Number of heparin-induced thrombocytopenia (HIT) events
时间窗: 30 days
This will be assessed by serum platelet factor 4 antibody level
Number of Cross-overs between arms
时间窗: 30 days
This will be assessed by number of cross over of patients from one arm to the other anti-coagulation arm for any particular clinical reason. Crossover patients will remain in the study and we will continue to collect protocol driven data. These patients will be analyzed separately from those with no cross-over.
次要结局
未报告次要终点