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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
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.
Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.
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.
Poznan University of Medical Sciences
Poznan, Poland
RECRUITINGTotal Blood Loss
Total blood loss expressed in ml/kg
Time frame: 24 hours postoperatively
Total Volume of Blood Transfusion
Total volume of transfused blood products (ml/kg) administered intraoperatively and within the first 24 hours postoperatively.
Time frame: 24 hours postoperatively
Hemoglobin Level
Hemoglobin concentration measured in g/dL
Time frame: immediately after surgery (0 hours)
Hemoglobin Level
Hemoglobin concentration measured in g/dL
Time frame: 24 hours postoperatively
Hematocrit Level
Hematocrit value (%)
Time frame: immediately after surgery (0 hours)
Hematocrit Level
Hematocrit value (%)
Time frame: 24 hours postoperatively
D-dimer Level
Plasma D-dimer concentration measured in mg/L
Time frame: 24 hours postoperatively
Fibrinogen Level
Plasma fibrinogen concentration measured in g/L
Time frame: 24 hours postoperatively
Prothrombin Time
Prothrombin time measured in seconds
Time frame: 24 hours postoperatively
Activated Partial Thromboplastin Time
Activated partial thromboplastin time measured in seconds
Time frame: 24 hours postoperatively
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