Non-Idiopathic Scoliosis Treated With Tranexamic Acid

Study Overview
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Brief Summary
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Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.

Detailed Description
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To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy). The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.

Official Title
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Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.

Conditions
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Non-idiopathic Scoliosis

Intervention / Treatment
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* Drug: Tranexamic acid 10mg/kg/hr
* Drug: Tranexamic acid 100 mg/kg/h infusion
* Drug: Saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Children with secondary scoliosis undergoing posterior spinal fusion Exclusion Criteria: Known bleeding disorder as this may increase the risk of bleeding Current antifibrinolytic therapy as these patients may bleed less Patient or family history of thromboembolic disease as there may be potential risk of thrombosis Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding Known allergy to TXA History of renal insufficiency as TXA is renally excreted Colour vision disturbance

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: . Tranexamic acid low dose 10 mg/kg<br> | Drug: Tranexamic acid 10mg/kg/hr<br>* Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator<br>* Other names: TXA;|
| Experimental: Tranexamic acid 100mg/kg<br> | Drug: Tranexamic acid 100 mg/kg/h infusion<br>* Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.<br>* Other names: TXA;|
| Placebo Comparator: Saline Placebo<br> | Drug: Saline solution<br>* Saline placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss and transfusion requirement |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis). |  | After Induction- Prior to Drug Administration, Immediately after Bolus Dose | 
| Plasminogen Activator Inhibitor-1 | Different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability. | Baseline -Immediately after induction and prior to administration of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, scoliosis, tranexamic acid, Investigating non-idiopathic scoliosis