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

Study Overview
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Tranexamic Acid (TXA)
* Drug: ε-Aminocaproic Acid (EACA)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid (TXA)<br>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. | Drug: Tranexamic Acid (TXA)<br>* 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.<br>* Other names: Cyklokapron;|
| Active Comparator: ε-Aminocaproic Acid (EACA)<br>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. | Drug: ε-Aminocaproic Acid (EACA)<br>* 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.<br>* Other names: Amicar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion rate |  | 1.5 to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, 6-Aminocaproic Acid, Arthroplasty, Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Antifibrinolytic Agents, Fibrin Modulating Agents, Pharmacologic Actions, Coagulants, Therapeutic Uses