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Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind Trial

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 10

Maximum Age: 18

Healthy Volunteers: f

View:

• Age 10 to 18 years

• Diagnosis of idiopathic scoliosis requiring surgical correction (posterior spinal fusion)

• American Society of Anesthesiologists (ASA) physical status I-II

• Written informed consent from parents or legal guardians and assent from the child

Locations

Other Locations

Poland

Poznan University of Medical Sciences

RECRUITING

Poznan

Contact Information

Primary

Malgorzata Reysner, MD PhD

mreysner@ump.edu.pl

+48 61 831-01-22

Backup

Piotr Janusz, MD PhD

pjanusz@um.edu.pl

Time Frame

Start Date: 2026-06-01

Estimated Completion Date: 2027-06-30

Participants

Target number of participants: 90

Treatments

Experimental: TXA Bolus + 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. Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.

Placebo_comparator: Placebo

0.9% sodium chloride (saline) administered intravenously in the same volumes and timing as the active comparator groups (bolus and infusion). All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.

Experimental: TXA 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). Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.

Related Therapeutic Areas

Seizures

Scoliosis

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