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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Epsilon Aminocaproic Acid
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic Acid<br>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: Tranexamic Acid<br>* 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.)<br>|
| Active Comparator: Epsilon Aminocaproic Acid<br>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: Epsilon Aminocaproic Acid<br>* 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).<br>|
| Placebo Comparator: Placebo<br>Control Normal Saline x 2 infusions as the double dummy for TXA and eACA. | Drug: Normal Saline<br>* Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss until the drain is removed |  | 24 hours |