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

Description

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.

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Study Design A double-blind, RCT comparing blood loss during total colpocleisis between patients receiving IV TXA and placebo. Conducted at a single academic urogynecology practice at a tertiary hospital. Patient Selection and Randomization Only patients undergoing total colpocleisis for posthysterectomy prolapse, with or without a midurethral sling, were considered. Exclusion criteria: preoperative hemoglobin <11 g/dL, concomitant hysterectomy, allergy or sensitivity to TXA, history of venous thromboembolic event, active thromboembolic disease, significant renal disease, taking medications that interact with TXA (oral estrogen, oral progestins, tretinoin, fibrinogen concentrate, anti-inhibitor coagulant complex), hematuria from a renal cause, acquired colour vision disturbances, subarachnoid hemorrhage, inability to provide consent due to language barriers or cognitive disabilities. Eligible patients providing written informed consent were enrolled on the day of surgery and randomly assigned in a 1:1 ratio to either the TXA group or the placebo group. The allocation scheme was generated through simple randomization using an online random number generator and held by hospital pharmacy who allocated patients. TXA and placebo bags were prepared by the hospital pharmacy to appear identical, ensuring blinding. Pharmacy labeled the bags with unique study number identifiers. The TXA bags contained 1g of TXA mixed with 67mL of normal saline, the placebo bags contained 67mL of normal saline. Preoperative Variables Recorded: age, body mass index, medical conditions, previous surgeries, allergies, and current prolapse stage. Total blood volume was calculated using weight (kg) x average demographic blood volume (65mL/kg). Hemoglobin and hematocrit were recorded from preoperative blood work done within one day to six weeks before surgery. Intraoperative Variables The study bag was collected from the hospital pharmacy and brought to the operating room. After anesthesia induction, the anesthesiologist administered the IV study bag. The following data was collected at the end of surgery: type of anesthesia, ASA classification, total surgical time, midurethral sling (retropubic or obturator), amount and type of IV fluid, amount and type of IV volume expander or blood product administered, amount and type of local anesthetic injected, and calculated blood loss (blood in the suction canisters + weighed blood in the surgical sponges). Surgeons, who were blinded to the volume of blood in the canisters and sponges during the surgery, were asked to provide an estimated blood loss volume at the end of surgery. Blood Loss Outcomes: hemoglobin/hematocrit taken on postoperative day 1, the time blood work was drawn, the difference between pre- and postoperative hemoglobin/hematocrit, and if blood transfusion or IV infusion of volume expander given after surgery. Safety Outcomes 6 weeks after surgery any adverse events between surgery and the appointment were recorded.

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