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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.)

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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).

Group Type ACTIVE_COMPARATOR

Epsilon Aminocaproic Acid

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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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.)

Intervention Type 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).

Intervention Type DRUG

Normal Saline

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No