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Non-Idiopathic Scoliosis Treated With Tranexamic Acid

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089140
First Posted: March 18, 2010
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tara Der, The Hospital for Sick Children
March 11, 2010
March 18, 2010
August 28, 2013
November 2014
November 2014   (Final data collection date for primary outcome measure)
Perioperative blood loss and transfusion requirement [ Time Frame: 8 hours ]
Same as current
Complete list of historical versions of study NCT01089140 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Same as current
Not Provided
Not Provided
 
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.
Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Non-idiopathic Scoliosis
  • 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
  • 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
  • Drug: Saline solution
    Saline placebo
  • Experimental: . Tranexamic acid low dose 10 mg/kg
    Intervention: Drug: Tranexamic acid 10mg/kg/hr
  • Experimental: Tranexamic acid 100mg/kg
    Intervention: Drug: Tranexamic acid 100 mg/kg/h infusion
  • Placebo Comparator: Saline Placebo
    Intervention: Drug: Saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
2
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01089140
1000013524
No
Not Provided
Not Provided
Tara Der, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Tara Der, M.sc. MD.,(FRCPC) Hospital for SickkIds
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP