Does Tranexamic Acid Reduce Blood Loss During Total Colpocleisis? An RCT

Objectives: To ascertain the efficacy of intravenous (IV) tranexamic acid (TXA) in reducing blood loss in women undergoing total colpocleisis, relative to a placebo control group.

Methods: This was a double-blind, randomized controlled trial including women undergoing total colpocleisis (+/-midurethral sling) for treatment of posthysterectomy pelvic organ prolapse, conducted at a single academic urogynecology practice in Canada (1/2018 – 3/2023). Patients were randomly assigned to either TXA or placebo groups. TXA (1 gram dose) or placebo IV bags were given after anesthesia induction and prepared identically to maintain blinding. Pre-operative data included demographics, medical information, and blood parameters. Primary outcomes: hemoglobin (hgb) and hematocrit (hct) differences from preoperative testing to 24 hours after surgery. Secondary outcomes: differences in intraoperative calculated blood loss (blood in cannister and weighed sponges, CBL) and need for blood transfusion. Safety outcomes were assessed at a six-week follow-up. Targeting a 25% reduction in blood loss, a sample size of 11 per group was determined. Accounting for potential dropouts, 30 patients were intended for recruitment. Outcome analyses adhered to the intention-to-treat principle using appropriate statistical tests.

Results: Of the 35 screened, 30 patients completed the study (TXA: 14; placebo: 16). Pre-operative variables and co-morbidities were similar between groups. Intra-operative outcomes were also comparable (Table 1) and all surgeries were done under general anesthesia. No significant differences were observed in any blood loss outcomes between TXA and placebo groups (Table 2: 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). Only one patient in the TXA group received a blood transfusion one day after surgery due to significant anemia. Safety outcomes revealed minor issues, with no significant adverse events related to the study intervention in the TXA group. In the placebo group, one patient experienced an upper gastrointestinal bleed two days after surgery, while another had a deep venous thrombosis five weeks after surgery, both considered unrelated to the study intervention.

LEGENDS
TABLE 1:
a.Median (IQR), Mann-Whitney test.
b.Number of patients (%), Chi-squared/Fisher’s exact tests.
TABLE 2:
a.Median (IQR), Mann-Whitney test.
b.Two patients in the placebo group did not have blood drawn after surgery so not included in post-operative analyses.

Conclusions: Despite contrasting findings in the surgical literature, 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 discernible advantage in blood loss metrics, 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. Further research into the efficacy of TXA in other pelvic reconstructive procedures is warranted.