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Non-Idiopathic Scoliosis Treated With Tranexamic Acid

Primary Purpose

Non-idiopathic Scoliosis

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic acid 10mg/kg/hr
Tranexamic acid 100 mg/kg/h infusion
Saline solution
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-idiopathic Scoliosis focused on measuring pediatrics, scoliosis, tranexamic acid, Investigating non-idiopathic scoliosis

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

. Tranexamic acid low dose 10 mg/kg

Tranexamic acid 100mg/kg

Saline Placebo

Arm Description

Outcomes

Primary Outcome Measures

Perioperative blood loss and transfusion requirement

Secondary Outcome Measures

Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis).
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.

Full Information

First Posted
March 11, 2010
Last Updated
July 11, 2019
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01089140
Brief Title
Non-Idiopathic Scoliosis Treated With Tranexamic Acid
Official Title
Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Inadequate number of potential participants
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-idiopathic Scoliosis
Keywords
pediatrics, scoliosis, tranexamic acid, Investigating non-idiopathic scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
. Tranexamic acid low dose 10 mg/kg
Arm Type
Experimental
Arm Title
Tranexamic acid 100mg/kg
Arm Type
Experimental
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid 10mg/kg/hr
Other Intervention Name(s)
TXA
Intervention Description
Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid 100 mg/kg/h infusion
Other Intervention Name(s)
TXA
Intervention Description
Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
Saline placebo
Primary Outcome Measure Information:
Title
Perioperative blood loss and transfusion requirement
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
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
Title
Plasminogen Activator Inhibitor-1
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Children with secondary scoliosis undergoing posterior spinal fusion Exclusion Criteria: Known bleeding disorder as this may increase the risk of bleeding Current antifibrinolytic therapy as these patients may bleed less Patient or family history of thromboembolic disease as there may be potential risk of thrombosis Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding Known allergy to TXA History of renal insufficiency as TXA is renally excreted Colour vision disturbance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Der, M.sc. MD.,(FRCPC)
Organizational Affiliation
Hospital for SickkIds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Non-Idiopathic Scoliosis Treated With Tranexamic Acid

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