BAR-TAX - Tranexamic Acid in Bariatric Surgery.

Condition(s) studied

Investigational drug(s) / intervention(s)

Tranexamic Acid (TXA): Tranexamic acid is administered intravenously according to a standardized perioperative regimen. Patients receive 2 g of tranexamic acid diluted in 250 mL of normal saline during anesthetic induction, followed by 2 g intravenously at 8 hours and 12 hours postoperatively. All patients are managed according to standardized perioperative care pathways, including venous thromboembolism prophylaxis and ERABS protocols.

Study 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.

Eligibility

Primary outcome measure(s)

• TAX and bleeding in bariatric surgery — 12 months
  To evaluate whether perioperative TAX use reduces the incidence of clinically significant bleeding within 48-72 hours after surgery (defined as at least one of the following: hemoglobin drop ≥2 g/dL with clinical signs, need for transfusion, bleeding requiring a procedure/endoscopy/surgery, hemodynamic instability attributable to bleeding).

Trial sites (1)

Other trials for the same condition