drugset / Trial / NCT01813058

Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

NCT01813058

Phase 1/2 Completed 120 enrolled Boston Children's Hospital
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2013-01
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 10 mg/kg Intravenous