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

Miller Orthopedic Specialists

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Tranexamic Acid (TXA); Drug: ε-Aminocaproic Acid (EACA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01873768

MOS1316735 (Other Identifier)

MOS-16735

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 2 patient groups

Tranexamic acid (TXA)

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid (TXA)

ε-Aminocaproic Acid (EACA)

Active Comparator group

Description:

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.

Treatment:

Drug: ε-Aminocaproic Acid (EACA)