Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
研究概览
简要总结
Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children undergoing elective cardiac surgery with cardiopulmonary bypass
排除标准
- •neonate born within 1 month
- •preoperative inotropes
- •preoperative mechanical ventilation
- •preexisting coagulation disorder
- •reoperation within 48 hours
- •significant liver or kidney disease
- •known allergy to TXA
研究组 & 干预措施
Tranexamic acid
50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit.
干预措施: Tranexamic Acid (Drug)
Placebo
same volume of normal saline was given.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
时间窗: 24 hours after surgery
次要结局
- episode of thrombotic complication(from drug administration to hospital discharge)
- blood loss 6 hours after surgery(6 hours after surgery)
- the amount of blood transfusion(24 hour after surgery)
- additional TXA administration(24 hours after surgery)
- re-exploration of chest for excess bleeding(within 24 hours after surgery)
- duration of mechanical ventilation(at the time of extubation)
- length of stay in intensive care unit(at the time of discharge from ICU)
- chest closure time (protamine to skin closure)(at the end of surgery)