Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Total Blood Loss — 24 hours postoperatively
  Total blood loss expressed in ml/kg

Trial sites (1)

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