Local Tranexamic Acid Infiltration for Prophylactic Hemorrhage Control in Vaginal Hysterectomy: Double-Blinded Randomized Placebo-Controlled Trial

Abstract Introduction and Hypothesis Tranexamic acid, an antifibrinolytic agent with a well-established safety profile, promotes hemostasis by inhibiting fibrin degradation. In recent years, intravenous tranexamic acid has gained wide acceptance as a prophylactic antihemorrhagic agent in surgical settings. However, data on its local administration remain limited. This study was designed to evaluate whether prophylactic local infiltration of tranexamic acid into cervical and vaginal tissues before surgery could reduce intraoperative blood loss. Methods A double-blind, randomized, placebo-controlled trial was conducted at a tertiary medical center between April 2022 and December 2024. Sixty women undergoing benign vaginal hysterectomy were randomized (1:1) to receive either 1 g TXA (in 10 ml saline) or placebo via local cervical/vaginal infiltration 5 min pre-incision. The primary outcome was delta hemoglobin (ΔHb; pre- to postoperative hemoglobin change). Outcomes were compared using appropriate tests ( t test or Mann–Whitney U , as indicated) with α = 0.05. Ethical approval was obtained from our institutional review board. Results Sixty patients were enrolled. Baseline characteristics of the two groups were comparable. The mean hemoglobin reduction was 1.48 ± 0.73 g/dl in the tranexamic acid group versus 1.27 ± 1.02 g/dl in controls ( p = 0.36). Estimated blood loss, transfusion rates, and operative parameters did not differ significantly. Mucosal dissection was significantly easier in the tranexamic acid group (86.7% vs 40.0%, p < 0.01). No thromboembolic events occurred. Conclusion Local prophylactic tranexamic acid did not reduce total blood loss. Vaginal hysterectomy remains a safe procedure with minimal bleeding.