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NCT07581457
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Conditions: Scoliosis Idiopathic, Scoliosis; Adolescence
Sex: All
Ages: 10 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Poznan University of Medical Sciences
Location: Poznan University of Medical Sciences Poznan
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 Criteria
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
Source: ClinicalTrials.gov (NCT07581457). StuddyBuddy aggregates publicly available trial information.