跳至主要内容
临床试验/NCT07192640
NCT07192640尚未招募不适用

PERIOPERATIVE USE OF INTRAVENOUS TRANEXAMIC ACID FOR HIGH BMI PATIENTS GOING THROUGH BARIATRIC SURGERIES

Ain Shams University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年10月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
试验地点
1
主要终点
Intraoperative blood Loss

研究概览

简要总结

Tranexamic acid is a promising option for minimizing blood loss in high-risk bariatric surgery patients, particularly in those with obesity, diabetes, and other comorbidities. When used appropriately, TXA can reduce the need for blood transfusions, maintain hemodynamic stability, and lower the incidence of complications related to blood loss.

详细描述

The impact of TXA in high-risk individuals undergoing bariatric surgery is of increasing interest, especially given the inherent risks of bleeding and complications associated with these procedures. Bariatric surgery, particularly procedures like Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy, carries a risk of significant blood loss, which may be exacerbated in patients who are morbid obese or have underlying comorbid conditions such as hypertension, diabetes, or coagulation disorders.

TXA can effectively reduce intraoperative and postoperative blood loss by stabilizing fibrin clots, which is critical in preventing the need for transfusions and reducing surgical complications. A few studies have explored the use of TXA in bariatric surgery because of the fear of associated increased incidence of embolic complications.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • High-risk patients, with obesity, BMI more than 45,
  • Patients with Preexisting cardiovascular condition, Hypertension, diabetes, or coagulation disorders, thyroid dysfunction and pulmonary disorders.

排除标准

  • patients with active thromboembolic disorders.
  • Patients with preexisting renal dysfunction,

研究组 & 干预措施

tranexamic group

Active Comparator

After induction of anesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg

干预措施: After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatr (Drug)

结局指标

主要结局

Intraoperative blood Loss

时间窗: "Perioperative"

Intraoperative and postoperative Blood Loss will be calculated in the suction and wet gauzes by blood and the need for blood transfusion will be recorded

次要结局

  • postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays(pre-intervention/surgery""Postoperative "up to 1 week")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabah Nageeb

anesthesia consultant

Ain Shams University

研究点 (1)

Loading locations...

相似试验