Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid Bolus Plus Infusion, Sodium Chloride 0.9% Inj, Tranexamic Acid Bolus Only.
- Who it may be relevant to
- Registry conditions: Scoliosis Idiopathic, Scoliosis; Adolescence. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind Trial
Overview
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.
Detailed description
Posterior spinal fusion for adolescent idiopathic scoliosis is associated with significant intraoperative blood loss and frequent need for blood transfusion. Tranexamic acid (TXA) is an antifibrinolytic agent that reduces bleeding, but optimal dosing strategies in pediatric scoliosis surgery remain unclear.
This study is a prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of two intravenous TXA regimens compared with placebo in children undergoing surgical correction of idiopathic scoliosis.
Participants aged 10-18 years will be randomly assigned to receive either TXA or placebo during surgery. All patients will undergo standardized anesthesia, regional analgesia, and intraoperative neuromonitoring according to institutional protocols.
The primary objective is to assess the effect of TXA on perioperative blood loss. Secondary objectives include evaluation of transfusion requirements, laboratory parameters, and safety outcomes.
Patients will be followed for 30 days after surgery to assess postoperative outcomes and adverse events.
Interventions
- Drug Tranexamic Acid Bolus Plus 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. - Drug Sodium Chloride 0.9% Inj
Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups. - Drug Tranexamic Acid 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.
Primary outcome measures
- Total Blood Loss [Time frame: 24 hours postoperatively]
Secondary outcome measures (9)
- Total Volume of Blood Transfusion [Time frame: 24 hours postoperatively]
- Hemoglobin Level [Time frame: immediately after surgery (0 hours)]
- Hemoglobin Level [Time frame: 24 hours postoperatively]
- Hematocrit Level [Time frame: immediately after surgery (0 hours)]
- Hematocrit Level [Time frame: 24 hours postoperatively]
- D-dimer Level [Time frame: 24 hours postoperatively]
- Fibrinogen Level [Time frame: 24 hours postoperatively]
- Prothrombin Time [Time frame: 24 hours postoperatively]
- Activated Partial Thromboplastin Time [Time frame: 24 hours postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Poznan University of Medical Sciences — Poznan
Identifiers
NCT: NCT07581457 · 2/2026