Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Time Spent at Goal Anticoagulation
研究概览
简要总结
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.
Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
详细描述
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.
The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 day to less than 18 years
- •Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit
- •receiving venovenous or venoarterial ECMO
排除标准
- •Patients with known or suspected heparin induced thrombocytopenia prior to consent
- •Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values
- •Patients with plan to decannulate from ECMO within 48 hours
- •Known or suspected pregnant women
- •Previous enrollment in this study
- •Primary language spoken that is not English or Spanish
研究组 & 干预措施
Unfractionated heparin group
Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.
干预措施: Unfractionated heparin (Drug)
Bivalirudin group
Patients randomized to this arm will receive anticoagulation with bivalirudin
干预措施: Bivalirudin (Drug)
结局指标
主要结局
Percentage of Time Spent at Goal Anticoagulation
时间窗: through study completion, an average of 1-2 weeks
次要结局
- Number of Participants With One or More Major Bleeding Events(through study completion, an average of 1-2 weeks)
研究者
Lakshmi Raman
PROFESSOR
University of Texas Southwestern Medical Center