Abstract / Summary
Abstract Background Tranexamic acid (TXA) has been increasingly evaluated in bariatric surgery; however, heterogeneity remains in dosing and timing, and the feasibility of implementing a standardized multidose regimen in routine practice is not well established. This pilot study evaluated implementation of a standardized three-dose intravenous TXA protocol in metabolic bariatric surgery. Methods This prospective, sequential-period pilot study included 1077 patients undergoing sleeve gastrectomy (SG), Roux-en-Y gastric bypass, or revisional surgery during alternating 3-month TXA and non-TXA periods. The primary outcome was feasibility, assessed by recruitment, protocol adherence, and completeness of 30-day outcome ascertainment. Postoperative bleeding, operative time (OT), length of stay (LOS), and thromboembolic events were evaluated exploratorily. Bleeding was assessed using Firth penalized logistic regression under intention-to-treat (ITT) and as-treated frameworks. Results Of 1,122 patients screened, 1077 were enrolled (96.0%; 95% CI 94.7–97.1%). Overall adherence to period-assigned treatment was 94.5% (95% CI 93.0–95.8%); all patients initiating TXA completed the three-dose regimen, and 30-day outcome ascertainment was 100.0% (95% CI 99.7–100.0%). Clinically significant bleeding occurred in 1.46% of patients assigned to TXA periods vs. 2.84% assigned to non-TXA periods ( p = 0.174). In ITT analysis, TXA allocation was not significantly associated with bleeding among SG patients (OR 0.55; 95% CI 0.10–2.53; p = 0.449), whereas anastomotic procedures had higher bleeding odds than SG (OR 5.41; 95% CI 1.86–18.64; p = 0.002). No treatment-by-procedure interaction was identified ( p = 0.985). OT and LOS were similar between groups, and no 30-day thromboembolic events occurred. Conclusion Implementation of a standardized three-dose intravenous TXA protocol was feasible within routine bariatric surgical practice, with high adherence and complete outcome ascertainment. Given the low bleeding event rate observed in this pilot, adequately powered studies are needed to determine whether TXA meaningfully reduces postoperative bleeding and whether its effect differs by procedure type.