Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compare the group with tranexamic acid with the group with saline solution.
研究概览
简要总结
Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements
详细描述
A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •First-time patients undergo surgical debridement of their burns.
- •A burn percentage of 10-30% of burned body surface area
- •Patients over 18 years of age
- •Patients under 40
- •IMSS beneficiaries
排除标准
- •Burned patients with previous surgical debridement.
- •Patients with co-morbids.
- •Patients with a history of drug hypersensitivity.
- •Patients with kidney disease.
研究组 & 干预措施
tranexamic acid
A total of 20 patients were included: 9 patients in the tranexamic acid group
干预措施: Tranexamic acid (Drug)
placebo
A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution.
干预措施: 0.9% isotonic saline solution (Other)
结局指标
主要结局
Compare the group with tranexamic acid with the group with saline solution.
时间窗: The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours.
The differences between the groups at the beginning of the study were evaluated with the Student's t test for continuous variables, and the proportions were compared with the Chi2 or Fisher test.
次要结局
未报告次要终点
研究者
GONZALEZ-OJEDA ALEJANDRO
Investigator
Instituto Mexicano del Seguro Social