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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

RecruitingNAAges 10 Years - 18 YearsAllPoznan University of Medical Sciences
NCT07581457 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Congenital or acquired coagulopathy * History of thromboembolic disease * History of seizures or epilepsy * Known hypersensitivity to tranexamic acid * Renal insufficiency (estimated glomerular filtration rate \< 60 mL/min/1.73 m²) * Cardiac arrhythmias or cardiovascular disease requiring antiplatelet or anticoagulant therapy
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What it tests

  • Tranexamic Acid Bolus Plus Infusion
  • Sodium Chloride 0.9% Inj
  • Tranexamic Acid Bolus Only
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Where

1 site
Poznan University of Medical Sciences
Poznan, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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