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

Abstract

BackgroundMultilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery.Methods/DesignHere 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.DiscussionThe 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.Trial RegistrationClinicalTrials.gov ID: NCT00958581

Management of operative blood loss in spinal deformity surgery

“…EACA seemed to be more effective as a method for blood loss reduction as the complexity of the surgery increased. 19 Recently, Verma et al 13 conducted a prospective, doubleblinded, randomized control trial comparing the use of TXA, EACA, and placebo used intraoperatively in patients undergoing surgery for adolescent idiopathic scoliosis. They found that TXA and EACA were both effective at reducing total blood loss, but not transfusions.…”

“…60 The accepted dosing for TXA is 10 mg/kg as a loading dose, with 1 mg/kg/hr for maintenance until incision closure, while the dosing for EACA is 100 mg/kg as loading dose, with 10 mg/kg/hr for maintenance until incision closure. 13 In the pediatric surgical literature, TXA doses as high as 100 mg/kg as a loading dose with 10 mg/kg/hr maintenance have been explored. 61 The ideal dose and duration of TXA for pediatric and adult scoliosis patients remains debated and is a direction for future study.…”

Pre-Operative Autologous Blood Donation Does Not Affect Pre-Incision Hematocrit in Adolescent Idiopathic Scoliosis Patients. A Retrospective Cohort of a Prospective Randomized Trial

“…8 During the prospective trial 125 patients were randomized to Tranexamic acid (TXA), Aminocaproic acid (EA-CA), or Saline (control) for surgery from January 2009 to January 2011. Level-1 data from this homogeneous population minimizes the effect of confounding variables.…”

“…All patients in the prospective study had a complete blood count drawn just prior to incision. 8 Of the 125 patients enrolled in that study: 28 patients donated blood prior to surgery (PD group), 97 patients did not pre-donate blood (Non-PD group). …”

“…In recent years this has driven surgeons to have greater focus on minimizing this risk through a variety of techniques including reduction of mean arterial pressure, meticulous surgical technique in conjunction with reduced operative time, and utilization of antifibrinolytic medications. 8 Various viruses such as HIV and Hepatitis B and C progressively contaminated donated allogenic blood in the 1980s. Therefore, healthcare professions sought to decrease the risk of exposure to contaminated products and in the late 1980s and 1990s many surgeons used PD for surgical procedures with large volumes of expected blood loss, such as in spinal surgery.…”