An interventional study of Tranexamic Acid Bolus Plus Infusion and Sodium Chloride 0.9% Inj in Scoliosis Idiopathic and Scoliosis; Adolescence, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 90 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tranexamic Acid Bolus Plus Infusion
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.
Drug: Sodium Chloride 0.9% Inj
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.
Drug: Tranexamic Acid Bolus Only
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.
Also known as: TXA bolus plus infusion; Tranexamic acid; TXA; Cyklokapron; Exacyl
Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.
Also known as: Normal Saline; NaCl 0.9%
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.
Also known as: TXA bolus only; Tranexamic acid; TXA; Cyklokapron; Exacyl
Total Blood Loss
Total blood loss expressed in ml/kg
Time frame: 24 hours postoperatively
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
Hemoglobin Level
Hemoglobin concentration measured in g/dL
Time frame: immediately after surgery (0 hours)
Hemoglobin Level
Hemoglobin concentration measured in g/dL
Time frame: 24 hours postoperatively
Hematocrit Level
Hematocrit value (%)
Time frame: immediately after surgery (0 hours)
Hematocrit Level
Hematocrit value (%)
Time frame: 24 hours postoperatively
D-dimer Level
Plasma D-dimer concentration measured in mg/L
Time frame: 24 hours postoperatively
Fibrinogen Level
Plasma fibrinogen concentration measured in g/L
Time frame: 24 hours postoperatively
Prothrombin Time
Prothrombin time measured in seconds
Time frame: 24 hours postoperatively
Activated Partial Thromboplastin Time
Activated partial thromboplastin time measured in seconds
Time frame: 24 hours postoperatively
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Poznan University of Medical Sciences →