Does Intravenous Tranexamic Acid Reduce Blood Loss at the Time of Total Colpocleisis? A Randomized Double-Blind Placebo-Controlled Trial

Objective: To determine the efficacy of intravenous (IV) tranexamic acid (TXA) in reducing blood loss and minimizing the necessity for blood transfusion among women undergoing total colpocleisis, relative to a placebo control group.
Design: Double-blind, randomized controlled trial.
Setting: Tertiary academic urogynecology practice.
Participants: Consenting women undergoing total colpocleisis (+/-midurethral sling) for treatment of posthysterectomy pelvic organ prolapse.
Interventions: Patients were randomly assigned to either TXA or placebo groups. TXA (1 gram dose) and placebo IV bags were given after anesthesia induction and prepared identically to maintain blinding. Primary outcome measures were the differences in hemoglobin (hgb) and hematocrit (hct) from preoperative testing to 24 hours after surgery. Secondary outcomes included the difference in intraoperative calculated blood loss (CBL – blood in canister plus weighed sponges) and the need for blood transfusion during hospital stay. Safety outcomes were assessed six weeks after surgery.
Results: Thirty patients completed the study (TXA: 14; placebo: 16). All preoperative variables were similar between groups. Intraoperative outcomes were also comparable, and all surgeries were done under general anesthesia. No significant differences were observed in any blood loss outcomes between groups (TXA – median hgb difference 3.2g/dL, median hct difference 0.09, median CBL 340mL; placebo – median hgb difference 2.6g/dL, median hct difference 0.08, median CBL 405mL). One patient in the TXA group received a blood transfusion one 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 disparity 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 enforces judicious use of TXA at the time of colpocleisis rather than use as a prophylactic drug.