Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
This trial is active, not recruiting.
|Treatments||tranexamic acid, epsilon aminocaproic acid, normal saline|
|Sponsor||Heekin Orthopedic Research Institute|
|Start date||April 2012|
|End date||December 2016|
|Trial size||54 participants|
|Trial identifier||NCT01527968, 242119|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Blood loss until the drain is removed
time frame: 24 hours
Male or female participants at least 21 years old.
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
|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|
|Principal investigator||R. David Heekin, M.D.|
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