TRanexamic Acid In Pediatric Scoliosis Surgery (TRIPSS): A Prospective Randomized Trial Comparing High Dose and Low Dose Tranexamic Acid in Adolescent Idiopathic Scoliosis (AIS) Undergoing Posterior Spinal Fusion Surgery.

Study design Prospective randomized double-blinded trial. Objective The objective of this study is to determine the efficacy of high dose versus low dose tranexamic acid (TXA) in adolescent idiopathic scoliosis (AIS) corrective surgery. Summary of background data Corrective surgery for AIS is associated with significant blood loss. Evidence on the optimum TXA dose to reduce bleeding in pediatric population is scarce. Methods 166 AIS patients aged between 10 to 21 years old, of American Society of Anesthesiologists (ASA) physical status I and II, preoperative hemoglobin > 10 g/dl, platelet count >150,000u/l and Cobb angle of >45° scheduled for elective single-stage posterior spinal fusion (PSF) surgery by two attending surgeons were included between March 2017 to November 2018. Patients were randomized into Group A (High Dose, 30 mg/kg TXA loading dose followed by 10 mg/kg/hour infusion) and Group B (Low dose, 10 mg/kg TXA loading dose followed by 1 mg/kg/hour infusion). The primary outcome was total surgical blood loss between both groups. Secondary outcomes were transfusion requirement, perioperative changes in hemoglobin and coagulation profiles, adverse events and factors that influence total blood loss. Results The mean total surgical blood loss between the two groups was not significant [Group A: 928.8 ± 406.1 ml (range: 348-1857 ml); Group B: 918.1 ± 406.0 ml (range: 271-2000 ml), p = 0.865]. The mean duration of surgery was 120 minutes. One patient in each group received allogenic blood transfusion during the perioperative period. There were no significant changes in hemoglobin and coagulation profile at pre-operation, post-operation 0 hour and 48 hours. Gender, number of vertebral levels fused and duration of surgery were independently associated with total surgical blood loss. No adverse events were observed perioperatively. Conclusions Low dose TXA was as efficacious as high dose TXA in reducing blood loss and allogenic blood transfusion for AIS patients undergoing PSF surgery.Level of Evidence: 1.