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

<p>Abstract</p> <p>Background</p> <p>Multilevel 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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov ID: NCT00958581</p

The relative efficacy of antifibrinolytics in adolescent idiopathic scoliosis: a prospective randomized trial.

BACKGROUND: Antifibrinolytics can reduce intraoperative blood loss. The primary aim of this study was to determine the efficacy of intraoperative tranexamic acid, epsilon-aminocaproic acid, and placebo at reducing perioperative blood loss and the transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal arthrodesis. METHODS: This is a prospective, randomized, double-blind comparison of tranexamic acid, epsilon-aminocaproic acid, and placebo used intraoperatively in patients with adolescent idiopathic scoliosis. One hundred and twenty-five patients with adolescent idiopathic scoliosis were randomly assigned to the tranexamic acid, epsilon-aminocaproic acid, or control groups. Parameters recorded included estimated blood loss, hematocrit, blood product usage, drain output, and total blood losses. The primary outcomes were intraoperative blood loss and postoperative drainage. Secondary outcomes were transfusion requirements and hematocrit changes both intraoperatively and postoperatively. RESULTS: One hundred and twenty-five patients (ninety-seven female and twenty-eight male, with a mean age of fifteen years) were randomized to receive tranexamic acid (thirty-six patients), epsilon-aminocaproic acid (forty-two patients), or saline solution (forty-seven patients). The groups were similar at baseline, with one exception: the saline solution group had a higher estimated blood volume at baseline than the tranexamic acid group. Both tranexamic acid and epsilon-aminocaproic acid reduced the estimated blood loss per degree and estimated blood loss per pedicle screw. Epsilon-aminocaproic acid, but not tranexamic acid, reduced estimated blood loss and estimated blood loss per level. Tranexamic acid also reduced total blood losses compared with epsilon-aminocaproic acid or saline solution. In an analysis controlling for level, degree, and number of anchors, tranexamic acid reduced drain output and total blood losses. Tranexamic acid or epsilon-aminocaproic acid had a smaller decrease in hematocrit postoperatively. In an analysis controlling for the mean arterial pressure during surgical exposure, tranexamic acid reduced estimated blood loss and total blood losses. Overall, antifibrinolytics (tranexamic acid or epsilon-aminocaproic acid) reduced estimated blood loss, total blood losses, and the decline in hematocrit postoperatively compared with saline solution. There was no difference among the groups with respect to the transfusion rate, duration of surgery, levels fused, or pedicle screws placed. CONCLUSIONS: Tranexamic acid and epsilon-aminocaproic acid reduced operative blood loss but not transfusion rate. Tranexamic acid is more effective at reducing postoperative drainage and total blood losses compared with epsilon-aminocaproic acid. Maintenance of the mean arterial pressure atbenefit. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence

Disc Degeneration in Unfused Caudal Motion Segments Ten Years Following Surgery for Adolescent Idiopathic Scoliosis.

HYPOTHESIS: The frequency of disc degeneration (DD) in the distal mobile segments will increase over time following surgery for adolescent idiopathic scoliosis (AIS). DESIGN: Retrospective review of a prospective AIS registry. INTRODUCTION: Durability of surgical outcomes is essential for maintenance of quality of life as well as for family decision making and for assessment of the value of a healthcare intervention. We assessed DD, its risk factors, and association with health-related quality of life 10 years after AIS surgery. METHODS: Five radiographic indicators of DD, previously validated, were evaluated preoperatively and 1 month, 2, 5, and 10 years postoperatively by a radiologist in operative AIS patients. A composite radiographic score (CRS; range 0-10) was calculated using the sum of each of the DD indicators. The severity of CRS in relation to the time point after surgery and various risk factors were assessed using linear regression or Pearson χ RESULTS: 193 consecutive patients (mean age at surgery 14.4 years; 86% female) were assessed. Surgical approach included 102 posterior and 91 anterior fusions. Contributors to maximum CRS at 10 years were Schmorl\u27s nodes (7.3% of patients), osteophytes (40.4%), sclerosis (29%), and irregular endplate (8.3%). CRS ≥3 occurred in 1.6%, 0.54%, 3.7%, 6.8%, and 7.3% of patients at the various time points (r CONCLUSION: In the first study of its kind, we found that only 7.3% of patients had significant DD 10 years after surgical correction of AIS. Rates of DD increased over time. Our data provide evidence to support recommendations to save as many caudal motion segments as possible, to avoid fusing to L4, and maintain the LIV tilt angle below 5° and LIV translation less than 2 cm

Establishing consensus on the best practice guidelines for the use of bracing in adolescent idiopathic scoliosis

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