Optimal dose of topical tranexamic acid considering efficacy and safety in total knee arthroplasty: a randomized controlled study

Purpose This study aimed to evaluate the optimal dosage of topical tranexamic acid (TXA) considering the efficacy and safety for controlling bleeding after total knee arthroplasty (TKA). Methods This prospective randomized double-blinded placebo-controlled comparative study included 325 patients scheduled to undergo TKA, who were randomly assigned to five groups based on the topical TXA injection ( n = 65 per group): control; group 1, 0.5 g TXA; group 2, 1.0 g TXA; group 3, 2.0 g TXA; and group 4, 3.0 g TXA. The primary outcome was decrease in postoperative hemoglobin levels. The secondary outcomes were blood loss calculated using Good’s method, drainage volume, frequency of transfusion, and range of motion (ROM). Plasma TXA levels and complications were also evaluated. Results Significant differences were noted in the decrease in hemoglobin levels between the control group and groups 2 ( p = 0.0027), 3 ( p = 0.005), and 4 ( p = 0.001). No significant differences were shown among the experimental groups. Significant differences in total blood loss and frequency of transfusion were noted between the control group and groups 2 ( p = 0.004, 0.002, respectively), 3 ( p = 0.007, 0.001, respectively), and 4 ( p = 0.001, 0.009, respectively) without showing significant differences among the experimental groups. With respect to drainage volume, no significant differences were observed among the groups. The serum TXA levels increased proportionally with the applied dose of topical TXA immediately and at 3 and 6 h postoperatively. Symptomatic deep vein thrombosis or pulmonary embolism was not observed in any group. Other complications related to TXA administration were not detected. Conclusion Topical application of 1.0 g or more of TXA shows significant bleeding control without a dose–response relationship. Blood TXA levels increase with the TXA dose following topical TXA application. Therefore, to prevent overdosing and reduce potential complications with ensuring the effectiveness, 1.0 g of TXA is recommended as a topical application. Level of evidence I.