The James A. Rand Young Investigator's Award: A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Total Knee Arthroplasty: The Same Efficacy at Lower Cost?

Background: Tranexamic acid (TXA) is a synthetic antifibrinolytic agent successfully used intravenously (IV) to reduce blood loss after total knee arthroplasty (TKA). An oral formulation of the medication is available, at a fraction of the cost of the IV preparation. The purpose of this randomized controlled trial is to determine if oral TXA is equivalent to IV TXA in reducing blood loss in TKA. Methods: In this double-blinded, placebo-controlled trial, patients undergoing primary TKA were randomized to receive 1.95g of TXA orally 2 hours preoperatively or 1g IV bolus before wound closure. The primary outcome was reduction of hemoglobin. Power analysis determined that 30 patients were required in each group. Equivalence analysis was performed with pooled and Satterthwaite t tests with a P-value of <.05 suggesting equivalence between treatments. Results: Thirty-four patients received oral TXA and 37 patients received IV TXA. There was no difference in the mean reduction of hemoglobin between oral and IV groups (3.45g/dL vs 3.31g/dL, respectively; P = .001, equivalence), and total blood loss was equivalent at 1281 mL vs 1231 mL, respectively (P = .02, equivalence). One patient in each group was transfused. Conclusion: Oral TXA provides equivalent reductions in blood loss, at a cost of $ 14 compared with $47-$108 depending on the IV formulation selected. As approximately 700,000 primary TKA are performed in the United States annually, a switch to oral TXA could yield total cost savings of between $ 23 million and $ 67 million dollars per year for our health care system. (C) 2016 Elsevier Inc. All rights reserved.