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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01527968
• Other study ID #: 242119
• Status: Active, not recruiting
• Phase: N/A
• First received: February 3, 2012
• Last updated: July 22, 2016
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Heekin Orthopedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• 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.)
• 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).
• Normal Saline
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heekin Orthopedic Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss until the drain is removed		24 hours	No