Health TrialsbyHealthPanel

Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

ConditionsScoliosis IdiopathicScoliosis; Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorPoznan University of Medical Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Congenital or acquired coagulopathy

History of thromboembolic disease

History of seizures or epilepsy

Known hypersensitivity to tranexamic acid

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: TXA Bolus + InfusionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: TXA Bolus OnlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Blood Loss

Total blood loss expressed in ml/kg

Time frame
24 hours postoperatively

Secondary outcomes

1

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
2

Hemoglobin Level

Hemoglobin concentration measured in g/dL

Time frame
immediately after surgery (0 hours)
3

Hemoglobin Level

Hemoglobin concentration measured in g/dL

Time frame
24 hours postoperatively
4

Hematocrit Level

Hematocrit value (%)

Time frame
immediately after surgery (0 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poznan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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