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
About this trial
This is an interventional treatment trial for Osteoarthritis
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
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
NCT ID
NCT01527968
First Posted
February 3, 2012
Last Updated
July 22, 2016
Sponsor
Heekin Orthopedic Research Institute
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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