The Effect of Tranexamic Acid and Gender on Intraoperative Bleeding in Orthognathic Surgery-A Randomized Controlled Trial.

Purpose: The purpose of this randomized trial was to measure the effect of intravenously administered tranexamic acid (TXA) on intraoperative blood loss (IOB) in patients undergoing bimaxillary orthognathic surgery (OS).

Materials And Methods: The authors designed and implemented a double-blinded placebo-controlled trial composed of patients eligible for OS at the Hospital of South West Denmark (Esbjerg, Denmark) from August 2014 through September 2016. The primary predictor variable was a single intravenous dose of TXA 1 g administered preoperatively or an equivalent saline placebo. The primary outcome was IOB determined by milliliters of blood in the suction canister and gauzes deducted from the volume of saline used intraoperatively.

Results: The study population consisted of 96 patients. The TXA group (n = 51) and the placebo group (n = 45) showed a median IOB of 275 and 403 mL (P = .005), respectively. A significant effect of TXA was detected in women (median IOB, 153 mL [96 to 233 mL] in TXA group vs 329 mL [185 to 582 mL] in placebo group; P < .001), whereas no significant effect of TXA on IOB was detected in men (median IOB, 367 mL [275 to 472 mL] in TXA group vs 429 mL [275 to 655 mL] in placebo group; P = .23). No correlations were found between IOB and procedure length, procedure type, or hematologic markers (platelets, hemoglobin, and hematocrit).

Conclusion: In contrast to other studies, this double-blinded randomized controlled trial found a hemostatic effect of TXA in women and none in men who underwent bimaxillary OS. To focus on the specific effect of TXA in men, future studies should include larger male samples.