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Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

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ClinicalTrials.gov Identifier: NCT01094977
Recruitment Status : Suspended (Inadequate funding)
First Posted : March 29, 2010
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tara Der, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE January 2010
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
Blood Loss [ Time Frame: Prior and Post Surgery ]
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
  • Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples [ Time Frame: Sample will be drawn immediately after induction and prior to administration of study drug ]
    PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery
  • Thromboelastography (TEG)Sample [ Time Frame: Baseline, immediately after bolus dose of TXA is infused ]
    TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
Official Title  ICMJE Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy
Brief Summary The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
Detailed Description

Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.

Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.

Recent studies in adults undergoing cardiac surgery demonstrated that people with 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 and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Craniosynostoses
Intervention  ICMJE
  • Drug: Tranexamic Acid
    10 mg/kg bolus with a 5 mg/kg/h infusion
  • Drug: Tranexamic Acid
    100 mg/kg bolus with a 10 mg/kg/h infusion
  • Drug: Saline Placebo
Study Arms  ICMJE
  • Experimental: Low Dose
    TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure
    Intervention: Drug: Tranexamic Acid
  • Experimental: High Dose
    TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Placebo
    Normal saline 10 ml before skin incision and infusion according to weight until skin closure
    Intervention: Drug: Saline Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 26, 2010)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction

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
  • Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094977
Other Study ID Numbers  ICMJE 1000013836
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tara Der, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tara Der, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date July 2019

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