Pharmacokinetics of Epsilon-Aminocaproic Acid in Children and Adolescents With Scoliosis Undergoing Posterior Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
研究概览
简要总结
This study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic acid (EACA) in children undergoing Posterior spinal fusion surgery (PSF) at The Children's Hospital of Philadelphia (CHOP) who receive EACA at the standard dose reported in the literature for this population and currently in use at CHOP.
详细描述
Posterior spinal fusion surgery (PSF) can be associated with significant blood loss, and perioperative transfusion is common. Various strategies have been employed to decrease intraoperative blood loss and reduce transfusion in children undergoing PSF. The intraoperative administration of the antifibrinolytic drug epsilon-aminocaproic acid (EACA) is one such strategy that has been shown to be effective in this regard. This study will evaluate the pharmacokinetics of EACA in children undergoing PSF at CHOP who receive EACA at the standard dose reported in the literature for this population and currently in use at CHOP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 8 to 18 years 2)Subjects undergoing posterior spinal fusion surgery 3)Subjects in whom aminocaproic acid administration is planned by the anesthesiology team 4)Parental/guardian permission (written informed consent) and when appropriate, child assent.
排除标准
- •Wards of the State are not eligible
- •Subjects with a history of abnormal renal function -
结局指标
主要结局
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
时间窗: up to 15 hours
The primary endpoint is the clearance of EACA
次要结局
- Determine population-specific EACA dosing strategies based on the observed EACA pharmacokinetics(one year)
- Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion(up to 15 hours)