Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery

Summary

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

Timeline

Start

2023-06-12

Primary completion

2025-07-31

Completion

2025-08-31

Outcome

Met primary endpoint

paper The treatment group receiving tranexemic acid, required significantly less number of haemostatic stitches for staple line bleeding (19 vs 46, p < 0.05) PMID 26694209 ↗

Publications

• Results Klaassen RA, Selles CA, van den Berg JW, Poelman MM, van der Harst E. Tranexamic acid therapy for postoperative bleeding after bariatric surgery. BMC Obes. 2018 Dec 3;5:36. doi: 10.1186/s40608-018-0213-5. eCollection 2018.
• Results Chakravartty S, Sarma DR, Chang A, Patel AG. Staple Line Bleeding in Sleeve Gastrectomy-a Simple and Cost-Effective Solution. Obes Surg. 2016 Jul;26(7):1422-8. doi: 10.1007/s11695-015-1986-y.
• Results Zafar SN, Miller K, Felton J, Wise ES, Kligman M. Postoperative bleeding after laparoscopic Roux en Y gastric bypass: predictors and consequences. Surg Endosc. 2019 Jan;33(1):272-280. doi: 10.1007/s00464-018-6365-z. Epub 2018 Sep 19.
• Results Augustin T, Aminian A, Romero-Talamas H, Rogula T, Schauer PR, Brethauer SA. Reoperative Surgery for Management of Early Complications After Gastric Bypass. Obes Surg. 2016 Feb;26(2):345-9. doi: 10.1007/s11695-015-1767-7.
• Results https://link.springer.com/article/10.1007/s00423-022-02630-5
• Results Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.
• Results Asif M, Aslam M, Altaf S, Atif S, Majid A. Prevalence and Sociodemographic Factors of Overweight and Obesity among Pakistani Adults. J Obes Metab Syndr. 2020 Mar 30;29(1):58-66. doi: 10.7570/jomes19039.

Drugs

Indications