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.
BACKGROUND
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov ID: NCT00958581.
Verma
Kushagra
K
Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases - Langone Medical Center, 301 East 17th St, New York, NY 10003, USA.
Errico
Thomas J
TJ
Vaz
Kenneth M
KM
Lonner
Baron S
BS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015119:Aminocaproic Acid / Q000627:therapeutic use*; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care; D012600:Scoliosis / Q000601:surgery; D013123:Spinal Fusion / Q000009:adverse effects*; D014148:Tranexamic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid; D015119:Aminocaproic Acid