A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery

Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure.The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes.ClinicalTrials.gov ID: NCT00958581Multilevel spinal fusion surgery has typically been associated with significant blood loss and transfusion requirements. Significant patient factors affecting operative blood loss include duration of exposure, severity and type of spinal deformity, and patient height [1-3]. Surgery dependent factors include operating time, procedure performed, combined anterior/posterior approaches, number of vertebrae fused, number of anchors placed, average mean arterial pressure (MAP) during surgery, blood salvage techniques, and the use of anti-fibrinolytic medications [4]. Factors with an unclear role include, but are not limited to: pre-operative hemoglobin, autologous donation, history of coagulopathy, prior use of anticoagulant medication, and type of fibrinolytic medication used in the operating room.Large quantities of intra-operative and postoperative blood loss require blood transfusion to maintain tissue perfusion and prevent end-organ damage. The use of allogenic blood, however, confers an additional risk for blood borne pathogens. Also noteworthy is the risk for transfusion related reactions, immune suppr