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临床试验/NCT07098780
NCT07098780招募中4 期

Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery

Patel Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年6月12日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
Need for additional intervention intra operative after administration of transamine

研究概览

简要总结

The goal of this clinical trial is to learn if tranexamic acid (TXA) helps reduce bleeding during bariatric surgery, such as laparoscopic sleeve gastrectomy (LSG) and mini gastric bypass (MGB). It will also look at how safe TXA is for people undergoing these procedures. The main questions it aims to answer are:

Does TXA reduce the amount of blood loss during bariatric surgery? Are there any side effects or complications in patients who receive TXA? Researchers will compare TXA to standard care (no TXA) to see if it is effective in reducing bleeding.

Participants will:

Receive either TXA or no TXA (placebo) before surgery Undergo standard bariatric surgery (LSG or MGB) Have their blood loss, hemoglobin levels, and any complications monitored during and after surgery

详细描述

STUDY BACKGROUND:

  1. Introduction Obesity, over the past few decades, has become an area of concern as leading to major non-communicable diseases such as cardiovascular diseases, hypertension, type 2 diabetes mellitus, dyslipidemia and cancer. It has been declared a global epidemic by WHO due to the large prevalence of overweight and obese populations. A cross-sectional study conducted in Multan, Pakistan (2019) revealed the prevalence of obesity in women is 30.2% and in men at 24.3%. (1) Bariatric surgery remains an effective method of weight reduction in patients with obesity refractory to diet and drug therapy. Bariatric surgery has been established as a standard of treatment for morbid obesity. Laparoscopic Sleeve Gastrectomy (LSG) and Roux-en-Y Gastric bypass (RYGB) remain the two common surgical techniques. (2) These procedures are generally safe and effective, postoperative complications such as anastomotic leak, hemorrhage, obstruction, and Venous Thromboembolism (VTE) add to associated morbidities with up to 2% risk of serious complications, i.e., bleeding, leak etc. (3)

Though the safety profile of LSG is superior to RYGB, bleeding still remains a significant morbidity peri-operative. (4) Available literature shows evidence of bleeding incidence to be 2-4%. (05) Hemorrhage in RYGB occurs roughly in 3% of the patients, (07) as compared to 2% in LSG. (08) These hemorrhagic events occur as staple line bleed, from mesenteric vessels and iatrogenic injury. () As hemorrhage leads to re-operation, various methods over time have been implied upon to reduce the risk of bleeding intra and post-operatively; these include suturing, buttressing, and human fibrin sealant.

Where these techniques appear to be complicated and expensive, a cost-effective and simpler solution could be the use of Tranexamic acid (TXA). Tranexamic acid is a synthetic lysine analogue that blocks lysine binding sites on plasminogen molecules hence inhibiting the formation of plasmin, thereby inhibiting fibrinolysis. TXA is being successfully used for various gynecological, orthopedic, and cardiothoracic procedures. Its role in bariatric surgery is not very well established. (09) Data on the use of TXA in reducing peri-operative bleeding is not readily available. A prospective cohort on the effectiveness of reducing staple line bleeding in LSG patients suggests the use of TXA to be safe and cost-effective (10). Another retrospective study reported a reduction in staple line bleed by use of TXA (44 patients were given TXA post-operatively, and only 04 out of this required re-operation.) () A retro prospective cohort study conducted on 314 patients undergoing LSG infers that TXA administration at the time on induction reduces hemorrhagic incidents and rate of re-operations. (05) Data on randomized controlled trials investigating the role of TXA in patients undergoing LSG and MGB is not available. 2. OBJECTIVE:

To determine the effectiveness of TXA in reducing hemorrhagic events when given prophylactically and post-operatively in patients undergoing LSG and MGB. 3. STUDY DESIGN:

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
Triple (Participant, Care Provider, Investigator)

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

  • Patients above 18 years of age AND
  • Undergoing Laparoscopic Sleeve Gastrectomy and MGB
  • Morbid obesity

排除标准

  • Patients on anti-platelets/anti-coagulants
  • Patients with inherited or acquired bleeding disorders
  • Patients with any acute medical condition predisposing to bleeding
  • Hormonal contraceptives
  • Known Allery to TXA
  • Female hormonal replacement therapy

研究组 & 干预措施

Transamine

Experimental

At the time of incision, 1000mg of the drug would be given intravenous, followed by two postoperative doses of 1000mg eight hours apart.

干预措施: Tranexamic Acid (Drug)

Placebo

Placebo Comparator

干预措施: Normal Saline (Placebo) (Other)

结局指标

主要结局

Need for additional intervention intra operative after administration of transamine

时间窗: From enrollment to 24 hours after surgical procedure

Bleeding event intraoperative Use of clips intraoperatively Staple line over sewing A drop in baseline hemoglobin in 24 hours Need for intervention post operative 24 hours (endoscopy or re-operation)

次要结局

未报告次要终点

研究者

发起方
Patel Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yusra Jamshed

Principal Investigator- Trainee General Surgery

Patel Hospital, Pakistan

研究点 (1)

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