Non-Idiopathic Scoliosis Treated With Tranexamic Acid
|Non-idiopathic Scoliosis||Drug: Tranexamic acid 10mg/kg/hr Drug: Tranexamic acid 100 mg/kg/h infusion Drug: Saline solution||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.|
- Perioperative blood loss and transfusion requirement [ Time Frame: 8 hours ]
- Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis). [ Time Frame: After Induction- Prior to Drug Administration, Immediately after Bolus Dose ]
- Plasminogen Activator Inhibitor-1 [ Time Frame: 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.
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
|Experimental: . Tranexamic acid low dose 10 mg/kg||
Drug: Tranexamic 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
Other Name: TXA
|Experimental: Tranexamic acid 100mg/kg||
Drug: Tranexamic 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.
Other Name: TXA
|Placebo Comparator: Saline Placebo||
Drug: Saline solution
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089140
|Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Tara Der, M.sc. MD.,(FRCPC)||Hospital for SickkIds|