Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bleeding loss
研究概览
简要总结
Massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. Since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and the transfusion during and after the surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the changes in coagulopathy will be defined using thromboelastography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for distraction osteostomy under the diagnosis of Craniosynostosis.
- •Patients aged from 2 months to 6 years, either of whose patients had consented
- •ASA class 1 or 2
排除标准
- •Coagulopathy with either PT > INR 1.5 or PLT < 50,000/dL
- •Patients took any NSAIDs within 2 days, or aspirin within 14 days prior to surgery
- •History of convulsive seizure, epilepsy, any brain surgery
- •Known drug allergic reaction to tranexamic acid
研究组 & 干预措施
Control
干预措施: normal saline (Drug)
Tranexamic acid
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Bleeding loss
时间窗: from every each hour during intraop, periodImmediate postop, postoperative 24hr to postoperative 48hr
Assessing the amount of bleeding during each intraop hours, and postoperative periods.
次要结局
未报告次要终点