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

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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Key information

Conditions

Osteoarthritis Arthritis Connective Tissue Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Miller Orthopedic Specialists

Council Bluffs, Iowa, 51503, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic acid (TXA)

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.

Other names: Cyklokapron

ε-Aminocaproic Acid (EACA)

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.

Other names: Amicar

Primary outcomes

Transfusion rate

Time frame: 1.5 to 2 years

Sponsors and collaborators

Lead sponsor

Miller Orthopedic Specialists

Other

Collaborators

CHI Health Mercy Hospital
Creighton University Medical Center

Registry information

Official study title

A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 10, 2013
Registry last updated: Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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