Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- intraoperative bleeding
研究概览
简要总结
Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.
详细描述
Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.
Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital
排除标准
- •Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;
- •Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
- •History of bleeding disorders in first-degree relatives;
- •Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
- •Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
- •Known allergy to tranexamic acid.
研究组 & 干预措施
Placebo
Saline infusion: Group receiving saline as placebo during the surgical procedure
干预措施: Saline (Drug)
Intervention
Tranexamic acid infusion: Group that received a Tranexamic acid bolus of 10mg / kg, followed by continuous infusion of 1 mg / kg / hr until the end of the procedure.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
intraoperative bleeding
时间窗: during surgery
Intraoperative bleeding volume defined as the sum of the volume of aspirated blood during the procedure and the volume of blood retained in the used gauze. The volume retained in the gauze was estimated by the difference between the dry weight and the weight after using them.
次要结局
- incidence of significant bleeding complications(During hospital stay, an expected average of 2 days)
- Incidence of wound dehiscence(5 days)
- Oronasal fistulas(1 month)
研究者
Guilherme Campelo Arantes
Guilherme Campelo Arantes MD
Professor Fernando Figueira Integral Medicine Institute