跳至主要内容
临床试验/NCT05696951
NCT05696951已完成不适用

Use of Tranexamic Acid in Postoperative Early Period Bleeding in Patients Undergoing Sleeve Gastrectomy: A Randomized Controlled Trial

Goztepe Prof Dr Suleyman Yalcın City Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
effect on bleeding in the first one hours postoperatively

研究概览

简要总结

The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.

详细描述

Prospective, comparative and double-blind study with patients aged 18-65 years admitted to bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA) during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar between groups. For statistical analysis, χ2 and analysis of variance tests were performed using the SPSS 21.0 ® statistical program at a significance level of p < 0.05.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III
  • undergoing bariatric surgery and LSG

排除标准

  • history of thromboembolic disease or severe comorbidity (ASA IV or more)
  • platelet antiaggregants or anticoagulants
  • active intravascular coagulation carriers
  • acute occlusive vasculopathy
  • hypersensitivity to the components of the TXA formula.

结局指标

主要结局

effect on bleeding in the first one hours postoperatively

时间窗: postoperative 1st hours

postoperative bleeding

次要结局

  • effect on bleeding in the first 24 hours postoperatively(postoperative 24st hours)

研究者

发起方
Goztepe Prof Dr Suleyman Yalcın City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Medeni Şermet

Specialist Medical doctor

Goztepe Prof Dr Suleyman Yalcın City Hospital

研究点 (2)

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Tranexamic Acid in Sleeve Gastrectomy | 临床试验