Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorPoznan University of Medical Sciences
About this trial
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
Qualifiers
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
Disqualifiers
Congenital or acquired coagulopathy
History of thromboembolic disease
History of seizures or epilepsy
Known hypersensitivity to tranexamic acid
Trial design
Treatments tested in this trial
- Tranexamic Acid Bolus Plus Infusion
- Sodium Chloride 0.9% Inj
- Tranexamic Acid Bolus Only
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov