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

Heekin Orthopedic Research Institute54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis

Interventions

Tranexamic AcidDRUG

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.)

Epsilon Aminocaproic AcidDRUG

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).

Normal SalineDRUG

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Blood loss until the drain is removed

Time frame: 24 hours

Data from ClinicalTrials.gov

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