drugset / Trial / NCT07581457

Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

NCT07581457

Recruiting 90 enrolled Poznan University of Medical Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate whether tranexamic acid (TXA), a medication used to reduce bleeding, is effective and safe in children undergoing surgery for idiopathic scoliosis. Significant blood loss is common during this type of surgery and often requires blood transfusions. Participants will be randomly assigned to one of three groups: (1) TXA given as an intravenous bolus followed by continuous infusion, (2) TXA given as two intravenous bolus doses, or (3) placebo (saline). Neither the patients nor the medical team will know which treatment is given. The main goal is to compare how much blood is lost during and after surgery and whether TXA reduces the need for blood transfusions. The study will also assess safety, including the risk of side effects such as seizures or blood clots. Patients will be followed for up to 30 days after surgery.

Timeline

Start
2026-06-01
Primary completion
2027-05-31
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 mg/kg Intravenous
Subject Tranexamic Acid Small molecule 10 mg/kg Intravenous