RESUMEN
BACKGROUND: Spinal reconstructive surgery in adults can be associated with significant blood loss, often requiring allogeneic blood transfusion. The objective of this randomized, prospective, double-blind, multicenter study was to evaluate the efficacy of tranexamic acid (TXA) in reducing perioperative blood loss and transfusion in adult patients having elective posterior thoracic/lumbar instrumented spinal fusion surgery. METHODS: One hundred fifty-one adult patients were randomized to receive either a bolus of 10 mg/kg IV of TXA after induction followed by a maintenance infusion of 1 mg/kg/hr of TXA, or an equivalent volume of placebo (normal saline). The primary outcome was the total perioperative estimated and calculated blood loss intraoperatively and 24 h postoperatively. Secondary outcomes were incidence of allogeneic blood exposure, and duration of hospital stay. RESULTS: Four patients were withdrawn for identifiable surgical bleeding, therefore 147 patients were included in the analysis. The total estimated and calculated perioperative blood loss was approximately 25% and 30% lower in patients given TXA versus placebo (1592 +/- 1315 mL vs 2138 +/- 1607 mL, P = 0.026; 3079 +/- 2558 vs 4363 +/- 3030, P = 0.017), respectively. There was no difference in the amounts of blood products transfused, and length of stay between the two groups. TXA, surgical duration, and number of vertebrae fused were independent factors related to perioperative blood loss. Predictors for the need for allogeneic red blood cell transfusion were ASA classification, surgical duration and number of levels fused. CONCLUSIONS: TXA significantly reduced the estimated and calculated total amount of perioperative blood loss in adult patients having elective posterior thoracic/lumbar instrumented spinal fusion surgery.