Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma Bivalirudin Concentration
研究概览
简要总结
This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB), or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patient (age less than 18 years)
- •weight > 3kg
- •scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and/or 3) the institution of extracorporeal support
- •must already require the administration of bivalirudin as part of their treatment plan
排除标准
- •Age equal to or greater than 18 years,
- •weight less than 3kg
- •end-stage renal failure requiring renal replacement therapy.
研究组 & 干预措施
Pediatric Cardiac Catheterization
干预措施: Bivalirudin (Drug)
Pediatric Cardiac Surgery
干预措施: Bivalirudin (Drug)
Pediatric Extracorporeal Life Support (ECLS)
干预措施: Bivalirudin (Drug)
结局指标
主要结局
Plasma Bivalirudin Concentration
时间窗: Throughout the duration of treatment with bivalirudin and for one hour after the infusion is stopped. To be specific: 1. In CPB and cath lab cases arm: average 6 hours. 2. In ECLS arm: average 10 days.
The primary end-point will be the plasma bivalirudin concentration (nanogram/mL) measured at multiple set time-points throughout the administration of bivalirudin in order to delineate the pharmacokinetic profile in the pediatric population.
次要结局
- thrombotic complications(Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment.)
- bleeding in excess of expectations for a given procedure or ECLS modality(Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment.)
- mortality(Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay or until death up to one year from enrollment.)
研究者
Katherine Zaleski
Instructor in Anaesthesia
Boston Children's Hospital