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Tranexamic acid is a potent antifibrinolytic, which has shown efficacy in reducing blood loss in total knee arthroplasty when administered intravenously. We performed a double-blind randomized controlled trial of oral tranexamic acid in total knee arthroplasty to assess the blood sparing effect of this preparation. We asked whether the oral formulation of tranexamic acid had significant benefit in the prevention of blood loss in total knee replacement arthroplasty.Forty-six patients undergoing unilateral total knee replacement arthroplasty for osteoarthritis were randomized to a treatment or control group (26 active tranexamic acid and 20 placebo). The treatment arm received three doses of 1500 mg encapsulated oral tranexamic acid at 8-hour intervals preoperatively, with the third dose occurring within 2 hours of surgery, and a fourth dose 6 hours postoperatively. The control arm received an identically encapsulated nonactive formulation at the same dosing intervals. Outcome measures were hemoglobin and hematocrit taken 24 hours postoperatively and total blood loss in wound drains at 24 hours. A record was made of any transfusion events occurring in either group as well as any thromboembolic complications. A follow-up phone call at 3 months was made to identify any late thromboembolic events.There was a significant reduction in blood drained at 24 hours (248 mL; P=0.34) as well as a significant decrease in the fall of both hemoglobin (P=0.02) and hematocrit (P=0.03) within the tranexamic acid group. No significant difference in transfusion events was found. Only one case of deep venous thrombosis occurred, and this was in the placebo group.Our study showed that oral tranexamic acid is efficacious as a blood sparing medication in total knee replacement arthroplasty and appears to be safe in a selected population.Therapeutic level 1.