Scoliosis Idiopathic, Scoliosis; Adolescence
Conditions
Brief 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.
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
DRUGTranexamic 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.
Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.
DRUGTranexamic 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.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Loss | 24 hours postoperatively | Total blood loss expressed in ml/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Volume of Blood Transfusion | 24 hours postoperatively | Total volume of transfused blood products (ml/kg) administered intraoperatively and within the first 24 hours postoperatively. |
| Hemoglobin Level | immediately after surgery (0 hours) | Hemoglobin concentration measured in g/dL |
| Hematocrit Level | immediately after surgery (0 hours) | Hematocrit value (%) |
| D-dimer Level | 24 hours postoperatively | Plasma D-dimer concentration measured in mg/L |
| Fibrinogen Level | 24 hours postoperatively | Plasma fibrinogen concentration measured in g/L |
| Prothrombin Time | 24 hours postoperatively | Prothrombin time measured in seconds |
| Activated Partial Thromboplastin Time | 24 hours postoperatively | Activated partial thromboplastin time measured in seconds |
Countries
Poland
Contacts
CONTACTMalgorzata Reysner, MD PhD
CONTACTPiotr Janusz, MD PhD
STUDY_CHAIRMałgorzata Reysner, MD PhD
Poznan University of Medical Sciences
Outcome results
None listed