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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07581457
Lead Sponsor Poznan University of Medical Sciences
Conditions
(from sponsor)		 Scoliosis Idiopathic, Scoliosis; Adolescence
Related terms Scoliosis
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov