Non-Idiopathic Scoliosis Treated With Tranexamic Acid

Phase 2

Terminated

• Conditions: Non-idiopathic Scoliosis
• Interventions: Drug: Saline solution; Drug: Tranexamic acid 10mg/kg/hr; Drug: Tranexamic acid 100 mg/kg/h infusion

• Registration Number: NCT01089140
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-18
• Study Start: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Saline Placebo	Saline solution	-
. Tranexamic acid low dose 10 mg/kg	Tranexamic acid 10mg/kg/hr	-
Tranexamic acid 100mg/kg	Tranexamic acid 100 mg/kg/h infusion	-

Primary Outcome Measures

Name	Time	Method
Perioperative blood loss and transfusion requirement	8 hours

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada