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Tranexamic Acid in Pediatric Cardiac Surgery (TXA)

Primary Purpose

Blood Loss, Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Okayama University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring pediatric cardiac surgery, bleeding, tranexamic acid, fibrinolysis, blood loss in pediatric cardiac surgery

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • neonate born within 1 month
  • preoperative inotropes
  • preoperative mechanical ventilation
  • preexisting coagulation disorder
  • reoperation within 48 hours
  • significant liver or kidney disease
  • known allergy to TXA

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Tranexamic acid

    Placebo

    Arm Description

    50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit.

    same volume of normal saline was given.

    Outcomes

    Primary Outcome Measures

    the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery

    Secondary Outcome Measures

    blood loss 6 hours after surgery
    the amount of blood transfusion
    additional TXA administration
    chest closure time (protamine to skin closure)
    re-exploration of chest for excess bleeding
    duration of mechanical ventilation
    length of stay in intensive care unit
    episode of thrombotic complication

    Full Information

    First Posted
    October 13, 2009
    Last Updated
    October 13, 2009
    Sponsor
    Okayama University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00994994
    Brief Title
    Tranexamic Acid in Pediatric Cardiac Surgery
    Acronym
    TXA
    Official Title
    Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Okayama University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss, Congenital Heart Disease
    Keywords
    pediatric cardiac surgery, bleeding, tranexamic acid, fibrinolysis, blood loss in pediatric cardiac surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic acid
    Arm Type
    Active Comparator
    Arm Description
    50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    same volume of normal saline was given.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    transamine, antifibrinolytic, lysin analogue
    Intervention Description
    50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.
    Primary Outcome Measure Information:
    Title
    the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
    Time Frame
    24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    blood loss 6 hours after surgery
    Time Frame
    6 hours after surgery
    Title
    the amount of blood transfusion
    Time Frame
    24 hour after surgery
    Title
    additional TXA administration
    Time Frame
    24 hours after surgery
    Title
    chest closure time (protamine to skin closure)
    Time Frame
    at the end of surgery
    Title
    re-exploration of chest for excess bleeding
    Time Frame
    within 24 hours after surgery
    Title
    duration of mechanical ventilation
    Time Frame
    at the time of extubation
    Title
    length of stay in intensive care unit
    Time Frame
    at the time of discharge from ICU
    Title
    episode of thrombotic complication
    Time Frame
    from drug administration to hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children undergoing elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: neonate born within 1 month preoperative inotropes preoperative mechanical ventilation preexisting coagulation disorder reoperation within 48 hours significant liver or kidney disease known allergy to TXA
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuichiro Toda, MD, PhD
    Organizational Affiliation
    Department of Anesthesiology and Intensive Care, Okayama University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21947753
    Citation
    Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24.
    Results Reference
    derived

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    Tranexamic Acid in Pediatric Cardiac Surgery

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