Clinical trial

Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07098780

Recruiting nowPhase 4Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionHemorrhage, Bariatric Surgery, Obesity, Morbid

Full registry criteria

Inclusion Criteria: * Patients above 18 years of age AND * Undergoing Laparoscopic Sleeve Gastrectomy and MGB * Morbid obesity Exclusion Criteria: * 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

Treatments and study arms

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.

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.

Primary outcomes

Need for additional intervention intra operative after administration of transamineFrom 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)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Patel Hospital🌐 Karachi, Sindh, Pakistan

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Shabana Tabbasum, MSc, PG Dip(Bioethics)Contact

Email · Call 021 111 174 174

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

Email · Call +923332064163

Yusra Jamshed, MBBSPrincipal Investigator