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

Heekin Orthopedic Research Institute

Status: Unknown

Conditions: Osteoarthritis

Treatments: Drug: Normal Saline; Drug: Epsilon Aminocaproic Acid; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01527968

242119

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups, including a placebo group

Tranexamic Acid

Active Comparator group

Description:

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.)

Treatment:

Drug: Tranexamic Acid

Epsilon Aminocaproic Acid

Active Comparator group

Description:

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).

Treatment:

Drug: Epsilon Aminocaproic Acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline