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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Sponsor: Poznan University of Medical Sciences
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.
Official title: Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind Trial
Key Details
Gender
All
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-06-01
Completion Date
2027-06-30
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
Tranexamic Acid Bolus Plus Infusion
Tranexamic acid administered intravenously as a 15 mg/kg bolus after induction of anesthesia, followed by continuous infusion at 1 mg/kg/h until the end of surgery.
Sodium Chloride 0.9% Inj
Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.
Tranexamic Acid Bolus Only
Tranexamic acid administered intravenously as two bolus doses: 10 mg/kg after induction of anesthesia and 10 mg/kg 120 minutes after surgical incision or at the beginning of rod placement, whichever occurs first.
Locations (1)
Poznan University of Medical Sciences
Poznan, Poland