NCT07581457 Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
| NCT ID | NCT07581457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Scoliosis Idiopathic |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-06-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Małgorzata Reysner, MD PhD
STUDY CHAIR
Poznan University of Medical Sciences
Frequently Asked Questions
Who can join the NCT07581457 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Scoliosis Idiopathic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07581457 currently recruiting?
Yes, NCT07581457 is actively recruiting participants. Contact the research team at mreysner@ump.edu.pl for enrollment information.
Where is the NCT07581457 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT07581457 clinical trial?
NCT07581457 is sponsored by Poznan University of Medical Sciences. The principal investigator is Małgorzata Reysner, MD PhD at Poznan University of Medical Sciences. The trial plans to enroll 90 participants.