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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Tranexamic Acid (TXA); Drug: ε-Aminocaproic Acid (EACA)

• Registration Number: NCT01873768
• Lead Sponsor: Miller Orthopedic Specialists

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid (TXA)	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.
ε-Aminocaproic Acid (EACA)	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.

Primary Outcome Measures

Name	Time	Method
Transfusion rate	1.5 to 2 years

Trial Locations

Locations (1)

Miller Orthopedic Specialists; 🇺🇸 Council Bluffs, Iowa, United States