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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2027
May 12, 2026
April 1, 2026
12 months
May 6, 2026
May 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total Blood Loss
Total blood loss expressed in ml/kg
24 hours postoperatively
Secondary Outcomes (9)
Total Volume of Blood Transfusion
24 hours postoperatively
Hemoglobin Level
immediately after surgery (0 hours)
Hemoglobin Level
24 hours postoperatively
Hematocrit Level
immediately after surgery (0 hours)
Hematocrit Level
24 hours postoperatively
- +4 more secondary outcomes
Study Arms (3)
TXA Bolus + Infusion
EXPERIMENTALTranexamic 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.
Placebo
PLACEBO COMPARATOR0.9% 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.
TXA Bolus Only
EXPERIMENTALTranexamic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, 62-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Małgorzata Reysner, MD PhD
Poznan University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2026
First Posted
May 12, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 12, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
- 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.
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.