Tranexamic acid to reduce bleeding in sleeve gastrectomy and mini gastric bypass
Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery
This trial will test whether giving tranexamic acid before laparoscopic sleeve gastrectomy or mini gastric bypass reduces bleeding in adults with morbid obesity.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Patel Hospital, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07098780 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase 4 trial comparing tranexamic acid given before surgery versus placebo in adults undergoing laparoscopic sleeve gastrectomy (LSG) or mini gastric bypass (MGB). Participants are randomized to receive either tranexamic acid or normal saline before their operation and then undergo standard perioperative care. Investigators will measure intraoperative blood loss, postoperative hemoglobin levels, and monitor for bleeding-related complications and other adverse events. The trial is conducted at a single site (Patel Hospital, Karachi) and excludes patients on anticoagulants, with bleeding disorders, or with known TXA allergy.
Who should consider this trial
Good fit: Adults (18 years and older) with morbid obesity scheduled for laparoscopic sleeve gastrectomy or mini gastric bypass who are not taking anticoagulant or antiplatelet medications and have no bleeding disorder are ideal candidates.
Not a fit: Patients on antiplatelet or anticoagulant therapy, those with inherited or acquired bleeding disorders, or those with a known allergy to tranexamic acid would be excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, tranexamic acid could reduce intraoperative and postoperative bleeding, lower transfusion needs, and decrease bleeding-related complications in bariatric surgery patients.
How similar studies have performed: Tranexamic acid has reduced surgical bleeding in many other specialties and some smaller bariatric studies suggest benefit, but large randomized evidence specifically in bariatric procedures is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karachi, Sindh
- Patel Hospital — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Yusra Jamshed, MBBS
- Email: yusra.j.khan@gmail.com
- Phone: +923343914332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.