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NCT Number: NCT07581457

Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location status: Recruiting

Location contact

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 61 873 83 03

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid Bolus Plus Infusion

Drug

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

Sodium Chloride 0.9% Inj

Drug

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%

Tranexamic Acid Bolus Only

Drug

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

Primary outcomes

  1. Total Blood Loss

    Time frame: 24 hours postoperatively

    Total blood loss expressed in ml/kg

Secondary outcomes

  1. Total Volume of Blood Transfusion

    Time frame: 24 hours postoperatively

    Total volume of transfused blood products (ml/kg) administered intraoperatively and within the first 24 hours postoperatively.

  2. Hemoglobin Level

    Time frame: immediately after surgery (0 hours)

    Hemoglobin concentration measured in g/dL

  3. Hemoglobin Level

    Time frame: 24 hours postoperatively

    Hemoglobin concentration measured in g/dL

  4. Hematocrit Level

    Time frame: immediately after surgery (0 hours)

    Hematocrit value (%)

  5. Hematocrit Level

    Time frame: 24 hours postoperatively

    Hematocrit value (%)

  6. D-dimer Level

    Time frame: 24 hours postoperatively

    Plasma D-dimer concentration measured in mg/L

  7. Fibrinogen Level

    Time frame: 24 hours postoperatively

    Plasma fibrinogen concentration measured in g/L

  8. Prothrombin Time

    Time frame: 24 hours postoperatively

    Prothrombin time measured in seconds

  9. Activated Partial Thromboplastin Time

    Time frame: 24 hours postoperatively

    Activated partial thromboplastin time measured in seconds

Study contacts

Contact information is provided by the study sponsor or research team.

Malgorzata Reysner, MD PhD

CONTACT

[email protected]

+48 61 831-01-22

Piotr Janusz, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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