Study objective: To determine the efficacy of intravenous (IV) tranexamic acid (TXA) in reducing blood loss and blood transfusion among women undergoing total colpocleisis.
Design: Double-blind, randomized, placebo-controlled trial.
Setting: Tertiary academic urogynecology practice.
Participants: Consenting women undergoing total colpocleisis (±midurethral sling) for treatment of posthysterectomy pelvic organ prolapse.
Interventions: Participants were randomly assigned to a single dose of 1gram TXA or placebo after anesthesia induction. Primary outcome measures were the differences in preoperative hemoglobin (hgb) and hematocrit (hct) compared to those measured 24 hours after surgery. Secondary outcomes included the difference in intraoperative blood loss and the need for blood transfusion during hospital stay. Safety outcomes were assessed 6 weeks postoperatively.
Main results: Thirty participants completed the study (TXA: 14; placebo: 16). Preoperative variables were similar between groups. Intraoperative outcomes were also comparable, and all surgeries were completed under general anesthesia. No significant differences were observed in any blood loss outcomes between groups (TXA versus placebo differences: hgb 3.2g/dL versus 2.6g/dL, p = .41; hct 0.09 versus 0.08, p = .25; intraoperative blood loss 340mL versus 405mL, p = .58). One patient in the TXA group received a blood transfusion 1 day after surgery due to medically significant anemia. There were no significant adverse events related to the study intervention in the TXA group.
Conclusion: This study showed no statistically significant differences in blood loss outcomes with the use of IV TXA at the time of total colpocleisis (±midurethral sling). While TXA administration showed no advantage regarding blood loss, it demonstrated no significant adverse effects. This study reinforces judicious use of TXA at the time of colpocleisis rather than using it prophylactically.