NCT01527968

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Heekin Orthopedic Research Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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.)
DRUG	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).
DRUG	Normal Saline	Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-02-07
• Last updated: 2016-07-26