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Non-Idiopathic Scoliosis Treated With Tranexamic Acid

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01089140
First received: March 11, 2010
Last updated: March 16, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Non-idiopathic Scoliosis
 Drug: Tranexamic acid 10mg/kg/hr
Drug: Tranexamic acid 100 mg/kg/h infusion
Drug: Saline solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Perioperative blood loss and transfusion requirement [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

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). [ Time Frame: After Induction- Prior to Drug Administration, Immediately after Bolus Dose ] [ Designated as safety issue: No ]
  • Plasminogen Activator Inhibitor-1 [ Time Frame: Baseline -Immediately after induction and prior to administration of study drug ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TXA
Placebo Comparator: Saline Placebo Drug: Saline solution
Saline placebo

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089140

Contacts
Contact: Carolyne Pehora, RN 416-813-7654 ext 2406 carolyne.pehora@sickkids.ca

Locations
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Principal Investigator: Tara Der, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Tara Der, M.sc. MD.,(FRCPC) Hospital for SickkIds
  More Information

No publications provided

Responsible Party: Dr.Tara Der, The Hospital For Sick Children
ClinicalTrials.gov Identifier: NCT01089140     History of Changes
Other Study ID Numbers: 1000013524
Study First Received: March 11, 2010
Last Updated: March 16, 2010
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
scoliosis
tranexamic acid
Investigating non-idiopathic scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Tissue Plasminogen Activator
Tranexamic Acid
Fibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Antifibrinolytic Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on May 23, 2013