Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- volume of intraoperative bleeding
研究概览
简要总结
The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.
详细描述
Tonsillectomy with or without adenoidectomy is the most common major surgical procedure performed in children. Although it's a relatively simple procedure, may present complications as hemorrhage and death. The mortality associated to the surgery range between 1/1.000 and 1/27.000 in the literature, with approximately 30% due to hemorrhage.
Tranexamic acid is an antifibrinolytic hemostatic indicated to control bleeding in cases of hyperfibrinolysis or defective hemostasis diseases. It's major indications are prostatic surgery and menorrhagia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with 4 to 12 years
- •adenotonsillar hypertrophy
- •indication of adenotonsillectomy
排除标准
- •patients with blood dyscrasia
- •patients with history of bleeding of difficult control or spontaneous hematoma
- •patients with coagulation tests altered
- •patients with evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or auto immune disease
研究组 & 干预措施
Tranexamic acid
干预措施: Tranexamic Acid (Drug)
Placebo
干预措施: normal saline solution (Other)
结局指标
主要结局
volume of intraoperative bleeding
时间窗: one day
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
次要结局
- incidence of postoperative bleeding(ten days)