Oral and intravenous tranexamic acid are equivalent at reducing blood loss following shoulder arthroplasty—A multicenter, double-blinded, randomized, placebo-controlled trial

Abstract

BackgroundTranexamic acid (TXA) has been shown to reduce blood loss significantly in shoulder arthroplasty. Oral TXA is significantly cheaper than intravenous TXA, but there has been no published literature comparing oral and intravenous TXA in shoulder arthroplasty. The purpose of this study was to compare the efficacy and safety of oral versus intravenous TXA in shoulder arthroplasty. We hypothesized that oral and intravenous TXA are equivalent at reducing blood loss following shoulder arthroplasty. MethodsThis study was approved by the New Zealand Health and Disability Ethics Committee (HDEC) and registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR). Patients undergoing elective shoulder arthroplasties were prospectively randomized into one of two groups. In the oral TXA group, 2g of TXA was administered two hours prior to induction of anesthesia, and in the intravenous TXA group, 1.5g of TXA was administered as a bolus following induction of anesthesia. The primary outcome was a reduction in hemoglobin concentration. The secondary outcomes included drain output, number of blood units transfused, length of hospital stay, and complications. ResultsA total of 80 consecutive patients were randomized. The baseline demographics were comparable between the two groups. There was no difference in the primary outcome measure or any of the secondary outcome measures. With regards to the primary outcome measure, using a two one-sided test (TOST) for equivalence, with a P value of < 0.05 demonstrating equivalence, the mean reduction of hemoglobin was 23.30g/L (± 1.62) versus 22.45g/L (± 1.30) for the oral and the intravenous groups, respectively (P < .001). Postoperative drain output was 74.58mLs (± 11.27) versus 90.03mLs (± 14.53) for the oral and the intravenous groups, respectively (P = .41). Furthermore, there was no difference in the number of blood units transfused, length of hospital stay, and complications. DiscussionTo the best of our knowledge, this is the first study in the literature comparing oral and intravenous tranexamic in shoulder arthroplasty, and we found no difference in the efficacy of the two routes of administration. Surgeons should be encouraged to use the less expensive oral form of the medication as a means to minimize overall healthcare expenditure.