Non-idiopathic Scoliosis
Conditions
Keywords
pediatrics, scoliosis, tranexamic acid, Investigating non-idiopathic scoliosis
Brief summary
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
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.
Interventions
DRUGTranexamic acid 10mg/kg/hr
Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator
DRUGTranexamic acid 100 mg/kg/h infusion
Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.
DRUGSaline solution
Saline placebo
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1\. Children with secondary scoliosis undergoing posterior spinal fusion
Exclusion criteria
1. Known bleeding disorder as this may increase the risk of bleeding 2. Current antifibrinolytic therapy as these patients may bleed less 3. Patient or family history of thromboembolic disease as there may be potential risk of thrombosis 4. Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding 5. Known allergy to TXA 6. History of renal insufficiency as TXA is renally excreted 7. Colour vision disturbance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative blood loss and transfusion requirement | 8 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline -Immediately after induction and prior to administration of study drug | 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. |
Countries
Canada
Outcome results
None listed