Trial | NCT01527968  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    54
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 Started
Apr 30
2012
Primary Completion
Dec 31
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Jul 26
2016
Estimate

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.

Tranexamic Acid 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.)

Epsilon Aminocaproic Acid 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).

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted