Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography
研究概览
简要总结
The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.
详细描述
Tranexamic acid (TXA) is administered intravenously to prevent bleeding associated with cardiac surgery and by pass in adult and children. The pharmacokinetic of this product is unknown in the pediatric population. Only a few studies report a clinical efficacy with different dosages. The purpose of this study is to determine the plasma level of TXA using two different administrations methods: continuous versus intermittent. The second objective is to determine whether fibrinolysis decreased. The population consists in children weighting 10 to 30 Kilos, undergoing cardiac surgery and at high risk of bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic
排除标准
- •the patients undergoing a surgical procedure short and simple
- •patients with past history of convulsions neurologiques especially allergies to the TA
- •patients with renal insufficiency
研究组 & 干预措施
INTERMITENT ADMINISTRATION
Administration of 10 mg/kg of Tranexamic Acid at the beginning ,the middle and at the end of the intervention
干预措施: Tranexamic Acid (Drug)
continuous administration of Tranexamic Acid
Administration of 10 mg /Kg of Tranexamic Acid at the beginning in the priming pump and continuous infusion of 1 mg/KG of Tranexamic Acid until the end of the intervention
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography
时间窗: Blood samples are collected during the operative period within 24 hours
次要结局
- preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography(blood samples collected during the operative period within the first 24 hours)