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

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Drug: Normal Saline; Drug: Epsilon Aminocaproic Acid; Drug: Tranexamic Acid

• Registration Number: NCT01527968
• Lead Sponsor: Heekin Orthopedic Research Institute

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 available

Study Timeline

• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Study Start: 2012-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-26
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal Saline	Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
Epsilon Aminocaproic Acid	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).
Tranexamic Acid	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.)

Primary Outcome Measures

Name	Time	Method
Blood loss until the drain is removed	24 hours