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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01873768

Enrollment

194

Registered

2013-06-10

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2016-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Tranexamic acid, 6-Aminocaproic Acid, Arthroplasty, Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Antifibrinolytic Agents, Fibrin Modulating Agents, Pharmacologic Actions, Coagulants, Therapeutic Uses

Brief summary

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.

Interventions

DRUGTranexamic 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.

DRUGε-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Transfusion rate	1.5 to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026