Non-Idiopathic Scoliosis Treated With Tranexamic Acid

July 11, 2019 updated by: Tara Der, The Hospital for Sick Children

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline Placebo
Drug: Saline solution
Saline placebo
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 Names:
  • 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 Names:
  • TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perioperative blood loss and transfusion requirement
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline -Immediately after induction and prior to administration of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Tara Der, M.sc. MD.,(FRCPC), Hospital for Sickkids

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000013524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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