Efficacy and Safety of Tranexamic Acid in Sleeve Gastrectomy: A Double-Blind Randomized Controlled Trial

Abstract

Intraoperative bleeding during sleeve gastrectomy (SG) can complicate dissection and increase transfusion risk. Tranexamic acid (TXA) is an antifibrinolytic agent with proven efficacy in reducing surgical blood loss, but its role in metabolic and bariatric surgery (MBS) remains uncertain. A single-center, randomized, double-blinded trial including 132 patients undergoing laparoscopic SG between July 2024 and July 2025 was conducted. Participants were randomized to receive 1 g intravenous TXA before incision or placebo. The primary outcome wasintroperative estimated blood loss (EBL).Perioperative estimated blood loss and Hemoglobin decline (ΔHb) served as key secondary confirmation. Secondary outcomes included intraoperative hemostatic measures, perioperative complications, and length of stay. Analyses were performed using intention-to-treat. The mean intraoperative estimated blood loss (EBL) was significantly lower in the TXA group compared with controls (118.6 ± 42.7 mL vs. 164.3 ± 51.2 mL, p < 0.001). Meanperioperative EBL was significantly lower in the TXA group compared with controls (270.4 ± 110.5 mL vs. 392.2 ± 136.6 mL, p < 0.001). Postoperative hemoglobin decline was also smaller with TXA (0.5 [0.4–0.8] g/dL vs. 0.9 [0.6–1.1] g/dL, p < 0.001). Patients receiving TXA required fewer intraoperative hemostatic clips and had fewer bleeding points. Operative time and length of stay were similar. No thromboembolic events, transfusions, or deaths occurred within 30 days. Complication rates did not differ between groups. A single preoperative dose of TXA reduced intraoperative blood loss and early hemoglobin decline in SG without evidence of increased short-term complications. Confirmation in larger multicenter cohorts is warranted before considering broader adoption in MBS practice. • Tranexamic acid (TXA) significantly reduced intraoperative blood loss during sleeve gastrectomy (SG). • TXA use was associated with a smaller decline in hemoglobin on postoperative day 1. • No thromboembolic events, transfusions, or deaths were observed within 30 days. • Safety outcomes and complication rates were similar between TXA and control groups.