NCT01089140

Non-Idiopathic Scoliosis Treated With Tranexamic Acid

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-idiopathic Scoliosis

Interventions

Type	Name	Description
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
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.
DRUG	Saline solution	Saline placebo

Timeline

• Start date: 2014-11-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2010-03-18
• Last updated: 2019-07-15

Locations

1 site across 1 country: Canada