Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss.

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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)

1g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 50ml of saline will be infused over 30 minutes beginning at the time of wound closure.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid (TXA)

Intervention Type DRUG

1g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 250cc of saline will be infused over 30 minutes beginning at the time of wound closure.

ε-Aminocaproic Acid (EACA)

7g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 50ml saline will be infused over 30 minutes beginning at the time of wound closure.

Group Type ACTIVE_COMPARATOR

ε-Aminocaproic Acid (EACA)

Intervention Type DRUG

7g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 250cc saline will be infused over 30 minutes beginning at the time of wound closure.

Interventions

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Tranexamic Acid (TXA)

1g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 250cc of saline will be infused over 30 minutes beginning at the time of wound closure.

Intervention Type DRUG

ε-Aminocaproic Acid (EACA)

7g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 250cc saline will be infused over 30 minutes beginning at the time of wound closure.

Intervention Type DRUG

Other Intervention Names

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Cyklokapron Amicar

Eligibility Criteria

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Inclusion Criteria

* Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery

Exclusion Criteria

* Non-English speaking individuals
* Individuals with a history of deep vein thrombosis or pulmonary embolism within one year
* Individuals with a history of coagulopathy
* Heart stent within one year
* Pre-operative autologous blood donation
* Unwilling or unable to take Coumadin for deep vein thrombosis (DVT) prophylaxis
* Received nonsteroidal anti-inflammatory drug (NSAID) or platelet antiaggregant treatment within five days prior to surgery
* Pre-operative creatinine greater than 1.5mg/dL

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No