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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid Bolus Plus Infusion | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss | Total blood loss expressed in ml/kg | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Volume of Blood Transfusion | Total volume of transfused blood products (ml/kg) administered intraoperatively and within the first 24 hours postoperatively. | 24 hours postoperatively |
| Hemoglobin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malgorzata Reysner, MD PhD | Contact | +48 61 831-01-22 | mreysner@ump.edu.pl | |
| Piotr Janusz, MD PhD | Contact | pjanusz@um.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Reysner, MD PhD | Poznan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Recruiting | Poznan | 62-701 | Poland |
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.
Data will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
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.
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Sodium Chloride 0.9% Inj | Drug | Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups. |
|
|
| Tranexamic Acid Bolus Only | Drug | 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. |
|
|
Hemoglobin concentration measured in g/dL
| immediately after surgery (0 hours) |
| Hemoglobin Level | Hemoglobin concentration measured in g/dL | 24 hours postoperatively |
| Hematocrit Level | Hematocrit value (%) | immediately after surgery (0 hours) |
| Hematocrit Level | Hematocrit value (%) | 24 hours postoperatively |
| D-dimer Level | Plasma D-dimer concentration measured in mg/L | 24 hours postoperatively |
| Fibrinogen Level | Plasma fibrinogen concentration measured in g/L | 24 hours postoperatively |
| Prothrombin Time | Prothrombin time measured in seconds | 24 hours postoperatively |
| Activated Partial Thromboplastin Time | Activated partial thromboplastin time measured in seconds | 24 hours postoperatively |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |