At a glance
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The Efficacy of Intravenous Tranexamic Acid in Decreasing Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
In Brief
A Phase 2 clinical trial evaluating Tranexamic Acid and Placebo for Adolescent Idiopathic Scoliosis. Completed, enrolled 120 participants across 1 site.
Detailed Summary
Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.
Study Details
Timeline
Interventions
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either: 1. placebo i.e. saline 0.9% (intravenous injection) 2. intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery.
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to: 1. Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or 2. TXA as previously described.