Non-Idiopathic Scoliosis Treated With Tranexamic Acid

Phase 2TerminatedNCT01089140

The Hospital for Sick Children2 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-idiopathic Scoliosis

Interventions

Tranexamic acid 10mg/kg/hrDRUG

Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator

Tranexamic acid 100 mg/kg/h infusionDRUG

Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.

Saline solutionDRUG

Saline placebo

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Perioperative blood loss and transfusion requirement

Time frame: 8 hours

Secondary Outcomes

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

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.

Time frame: Baseline -Immediately after induction and prior to administration of study drug

Data from ClinicalTrials.gov

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