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Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Epsilon Aminocaproic Acid
Normal Saline
Sponsored by
Heekin Orthopedic Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients scheduled to receive primary unilateral total knee arthroplasty

Exclusion Criteria:

  • Subject requires bilateral staged total knee arthroplasty
  • Religious beliefs that would limit blood transfusion
  • History of acquired defective color vision (inhibits monitoring for adverse events)
  • Patients with a known history of upper urinary tract bleeding
  • History of abnormal coagulation
  • Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery
  • Active intravascular clotting
  • Known allergy to either TXA or eACA
  • Myocardial Infarct within 6 months
  • History of stroke
  • Patient is a prisoner

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Tranexamic Acid

    Epsilon Aminocaproic Acid

    Placebo

    Arm Description

    TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)

    eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).

    Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

    Outcomes

    Primary Outcome Measures

    Blood loss until the drain is removed

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2012
    Last Updated
    July 22, 2016
    Sponsor
    Heekin Orthopedic Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01527968
    Brief Title
    Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
    Official Title
    A Prospective, Randomized, Double Blind, Double-Dummy Study Comparing the Safety and Efficacy of Epsilon Aminocaproic Acid (eACA) Versus Tranexamic Acid (TXA) Versus Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Heekin Orthopedic Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic Acid
    Arm Type
    Active Comparator
    Arm Description
    TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
    Arm Title
    Epsilon Aminocaproic Acid
    Arm Type
    Active Comparator
    Arm Description
    eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Intervention Description
    TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
    Intervention Type
    Drug
    Intervention Name(s)
    Epsilon Aminocaproic Acid
    Intervention Description
    eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Intervention Description
    Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
    Primary Outcome Measure Information:
    Title
    Blood loss until the drain is removed
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients scheduled to receive primary unilateral total knee arthroplasty Exclusion Criteria: Subject requires bilateral staged total knee arthroplasty Religious beliefs that would limit blood transfusion History of acquired defective color vision (inhibits monitoring for adverse events) Patients with a known history of upper urinary tract bleeding History of abnormal coagulation Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery Active intravascular clotting Known allergy to either TXA or eACA Myocardial Infarct within 6 months History of stroke Patient is a prisoner
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    R. David Heekin, M.D.
    Organizational Affiliation
    Heekin Institute for Orthopedic Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty

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