Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Scoliosis Idiopathic; Scoliosis; Adolescence
• Intervention / Treatment: Drug: Tranexamic Acid Bolus Plus Infusion; Drug: Sodium Chloride 0.9% Inj; Drug: Tranexamic Acid Bolus Only

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malgorzata Reysner, MD PhD; Phone Number: +48 61 831-01-22; Email: mreysner@ump.edu.pl
• Study Contact Backup: Name: Piotr Janusz, MD PhD; Email: pjanusz@um.edu.pl

Study Locations

• Poland
  • Poznan, Poland, 62-701
    • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXA Bolus + 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. Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.	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.; Other Names: TXA bolus plus infusion; Tranexamic acid; TXA; Cyklokapron; Exacyl
Placebo Comparator: Placebo; 0.9% sodium chloride (saline) administered intravenously in the same volumes and timing as the active comparator groups (bolus and infusion). All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.	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.; Other Names: Normal Saline; NaCl 0.9%
Experimental: TXA 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). Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring.	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.; Other Names: TXA bolus only; Tranexamic acid; TXA; Cyklokapron; Exacyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Blood Loss	Total blood loss expressed in ml/kg	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Volume of Blood Transfusion	Total volume of transfused blood products (ml/kg) administered intraoperatively and within the first 24 hours postoperatively.	24 hours postoperatively
Hemoglobin Level	Hemoglobin concentration measured in g/dL	immediately after surgery (0 hours)
Hemoglobin Level	Hemoglobin concentration measured in g/dL	24 hours postoperatively
Hematocrit Level	Hematocrit value (%)	immediately after surgery (0 hours)
Hematocrit Level	Hematocrit value (%)	24 hours postoperatively
D-dimer Level	Plasma D-dimer concentration measured in mg/L	24 hours postoperatively
Fibrinogen Level	Plasma fibrinogen concentration measured in g/L	24 hours postoperatively
Prothrombin Time	Prothrombin time measured in seconds	24 hours postoperatively
Activated Partial Thromboplastin Time	Activated partial thromboplastin time measured in seconds	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Małgorzata Reysner, MD PhD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Organic Chemicals; Pharmaceutical Preparations; Carboxylic Acids; Inorganic Chemicals; Chlorine Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Chlorides; Hydrochloric Acid; Tranexamic Acid; Saline Solution; Sodium Chloride
• Other Study ID Numbers: 2/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) underlying the results reported in this study, after de-identification, will be shared. This includes demographic data, perioperative variables, laboratory results, and outcome measures. Supporting documents such as the study protocol and statistical analysis plan will also be available.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the principal investigator. Data access will be granted following approval by the study investigators and after signing a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No