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Topical application of tranexamic acid to bleeding wound surfaces reduces blood loss in patients undergoing some major surgeries, without systemic complications. The objective of the present trial was to assess the efficacy and safety of the topical application of tranexamic acid on postoperative blood loss in patients undergoing primary unilateral total knee arthroplasty with cement.In a prospective, double-blind, placebo-controlled trial, 124 patients were randomized to receive 1.5 or 3.0 g of tranexamic acid in 100 mL of normal saline solution or an equivalent volume of placebo (normal saline solution) applied into the joint for five minutes at the end of surgery. The primary outcome was blood loss calculated from the difference between the preoperative hemoglobin level and the corresponding lowest postoperative value or hemoglobin level prior to transfusion. The safety outcomes included Doppler ultrasound in all patients and measurement of plasma levels of tranexamic acid one hour after release of the tourniquet.Twenty-five patients were withdrawn for various reasons; therefore, ninety-nine patients were included in the intention-to-treat analysis. The postoperative blood loss was reduced in the 1.5 and 3-g tranexamic acid groups (1295 mL [95% confidence interval, 1167 to 1422 mL] and 1208 mL [95% confidence interval, 1078 to 1339 mL], respectively) in comparison with the placebo group (1610 mL [95% confidence interval, 1480 to 1738 mL]) (p < 0.017). The postoperative hemoglobin levels were higher in the 1.5 and 3.0-g tranexamic acid groups (10.0 g/dL [95% confidence interval, 9.5 to 10.4 g/dL] and 10.1 g/dL [95% confidence interval, 9.8 to 10.5 g/dL], respectively) in comparison with the placebo group (8.6 g/dL [95% confidence interval, 8.2 to 9 g/dL]) (p < 0.017). With the numbers studied, there was no difference in the rates of deep-vein thrombosis or pulmonary embolism between the three groups. Minimal systemic absorption of tranexamic acid was observed.At the conclusion of a total knee arthroplasty with cement, topical application of tranexamic acid directly into the surgical wound reduced postoperative bleeding by 20% to 25%, or 300 to 400 mL, resulting in 16% to 17% higher postoperative hemoglobin levels compared with placebo, with no clinically important increase in complications being identified in the treatment groups.Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.