Overview

This trial is active, not recruiting.

Condition osteoarthritis
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.)
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.)
(Active Comparator)
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).
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).
(Placebo Comparator)
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
normal saline
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

Primary Outcomes

Measure
Blood loss until the drain is removed
time frame: 24 hours

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Heekin Orthopedic Research Institute.