drugset / Trial / NCT07401394

BAR-TAX - Tranexamic Acid in Bariatric Surgery.

NCT07401394

Active not recruiting 1000 enrolled Santa Maria Hospital - GVM Care & Research
NaSingle-groupOpen-labelPrevention

Summary

Perioperative bleeding is a relevant complication in bariatric surgery and may lead to hemoglobin decrease, blood transfusions, reinterventions, prolonged hospital stay, and increased healthcare costs. Tranexamic acid (TXA), an antifibrinolytic agent, has demonstrated efficacy in reducing surgical bleeding in several surgical specialties, with a favorable safety profile when appropriately used. However, evidence in bariatric surgery remains limited, particularly considering the intrinsically increased thromboembolic risk of obese patients. The BAR-TAX study is a prospective, single-center study conducted in a high-volume bariatric surgery center, aiming to evaluate the efficacy and safety of perioperative TXA administration compared with standard care without TXA. The primary objective is to assess whether TXA reduces the incidence of clinically significant bleeding within 48-72 hours after bariatric surgery. Secondary objectives include evaluation of hemoglobin drop, transfusion rates, need for hemostatic procedures or reoperation, thromboembolic events, postoperative complications, length of hospital stay, readmissions, and TXA-related adverse events.

Timeline

Start
2025-12-01
Primary completion
2026-06-30
Completion
2026-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 2 g Intravenous

Indications