Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery

NCT07098780 | Recruiting Phase 4

• 1 other identifier: PH/IRB/2023/011
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hemorrhage; Bariatric Surgery; Obesity, Morbid

Keywords

Bariatric surgery; Tranexamic Acid; Hemorrhage in bariatric surgery; RCT; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Need for additional intervention intra operative after administration of transamine

  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)

  From enrollment to 24 hours after surgical procedure

Study Arms (2)

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.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Other: Normal Saline (Placebo)

Interventions

Tranexamic Acid DRUG

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

Transamine

Normal Saline (Placebo) OTHER

At the time of incision, 10ml of the drug would be given intravenous, followed by two postoperative doses of 10ml eight hours apart.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patel Hospital, Pakistan: lead

Study Sites (1)

Patel Hospital

Karachi, Sindh, 75300, Pakistan

RECRUITING

Related Publications (7)

• 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.

  PMID: 30524741 BACKGROUND

• 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.

  PMID: 26694209 BACKGROUND

• 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.

  PMID: 30232617 BACKGROUND

• 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.

  PMID: 26140855 BACKGROUND

• https://link.springer.com/article/10.1007/s00423-022-02630-5

  BACKGROUND

• 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.

  PMID: 27230645 BACKGROUND

• 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.

  PMID: 32045513 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Obesity, Morbid

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ghulam Murtaza, MBBS, FCPS, MRCS, MSc (epi)

  Patel Hospital

  STUDY DIRECTOR

Central Study Contacts

Yusra Jamshed, MBBS

CONTACT

+923343914332; yusra.j.khan@gmail.com

Umama Ehtisham, MBBS

CONTACT

+923323551441; umamas15@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Trainee General Surgery

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 1, 2025
• Study Start: June 12, 2023
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)