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Trial record 12 of 30 for:    "Collagen Disease" | "Tranexamic Acid"

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

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ClinicalTrials.gov Identifier: NCT01527968
Recruitment Status : Unknown
Verified July 2016 by R. David Heekin, MD, Heekin Orthopedic Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2012
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
R. David Heekin, MD, Heekin Orthopedic Research Institute

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Blood loss until the drain is removed [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01527968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Tranexamic Acid
    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.)
  • Drug: Epsilon Aminocaproic Acid
    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).
  • Drug: Normal Saline
    Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
Study Arms  ICMJE
  • Active Comparator: Tranexamic Acid
    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: Drug: Tranexamic Acid
  • Active Comparator: Epsilon Aminocaproic Acid
    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: Drug: Epsilon Aminocaproic Acid
  • Placebo Comparator: Placebo
    Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
    Intervention: Drug: Normal Saline
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: February 6, 2012)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01527968
Other Study ID Numbers  ICMJE 242119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R. David Heekin, MD, Heekin Orthopedic Research Institute
Study Sponsor  ICMJE Heekin Orthopedic Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R. David Heekin, M.D. Heekin Institute for Orthopedic Research
PRS Account Heekin Orthopedic Research Institute
Verification Date July 2016

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