Scoliosis IdiopathicNCT07581457
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
A study testing Tranexamic Acid Bolus Plus Infusion, Sodium Chloride 0.9% Inj and Tranexamic Acid Bolus Only in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Adolescence
- What is being tested?
- Tranexamic Acid Bolus Plus Infusion, Sodium Chloride 0.9% Inj and Tranexamic Acid Bolus Only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Piotr Janusz, MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Being tested
- Tranexamic Acid Bolus Plus Infusion, Sodium Chloride 0.9% Inj, Tranexamic Acid Bolus Only
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Bolus Plus InfusionDrug
Also called TXA bolus plus infusion; Tranexamic acid; TXA; Cyklokapron; Exacyl
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% InjDrug
Also called Normal Saline; NaCl 0.9%
Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.
Tranexamic Acid Bolus OnlyDrug
Also called TXA bolus only; Tranexamic acid; TXA; Cyklokapron; Exacyl
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.
| Study group | Role | What they receive |
|---|---|---|
| TXA Bolus + Infusion | Experimental | 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. Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring. Receives: Drug: Tranexamic Acid Bolus Plus Infusion |
| Placebo | Placebo comparator | 0.9% 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. Receives: Drug: Sodium Chloride 0.9% Inj |
| TXA Bolus Only | Experimental | 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). Maximum total dose not exceeding 2 g. All patients receive standardized anesthesia (TIVA with propofol and remifentanil), erector spinae plane block, and intraoperative neuromonitoring. Receives: Drug: Tranexamic Acid Bolus Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss
Total blood loss expressed in ml/kg
Measured: 24 hours postoperatively
Secondary outcomes (9)
Total Volume of Blood Transfusion
Total volume of transfused blood products (ml/kg) administered intraoperatively and within the first 24 hours postoperatively.
Measured: 24 hours postoperatively
Hemoglobin Level
Hemoglobin concentration measured in g/dL
Measured: immediately after surgery (0 hours)
Hemoglobin Level
Hemoglobin concentration measured in g/dL
Measured: 24 hours postoperatively
Hematocrit Level
Hematocrit value (%)
Measured: immediately after surgery (0 hours)
Hematocrit Level
Hematocrit value (%)
Measured: 24 hours postoperatively
D-dimer Level
Plasma D-dimer concentration measured in mg/L
Measured: 24 hours postoperatively
Fibrinogen Level
Plasma fibrinogen concentration measured in g/L
Measured: 24 hours postoperatively
Prothrombin Time
Prothrombin time measured in seconds
Measured: 24 hours postoperatively
Activated Partial Thromboplastin Time
Activated partial thromboplastin time measured in seconds
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581457
- Sponsor's protocol ID
- 2/2026
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.