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New treatment option for Scoliosis Idiopathic
Official title Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
ClinicalTrials.gov ID: NCT07581457
What this study is testing
What is Tranexamic Acid Bolus Plus Infusion?
Tranexamic Acid Bolus Plus Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for scoliosis idiopathic.
Also referred to as TXA bolus plus infusion; Tranexamic acid; TXA; Cyklokapron; Exacyl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join 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 likely can't join 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
The study team makes the final eligibility decision.
Where it's taking place
- Poznan, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poznan, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.