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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01873768
• Other study ID #: MOS-16735
• Secondary ID: MOS1316735
• Status: Recruiting
• Phase: Phase 4
• First received: June 6, 2013
• Last updated: April 6, 2015
• Start date: January 2014
• Est. completion date: July 2016

Study information

• Verified date: April 2015
• Source: Miller Orthopedic Specialists
• Contact: Clifford K Boese, MD
• Phone: 712-323-5333
• Email: ckb[@]millerortho.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 372
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Tranexamic 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.
• e-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.

Locations

Country	Name	City	State
United States	Miller Orthopedic Specialists	Council Bluffs	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Miller Orthopedic Specialists	CHI Health Mercy Hospital, Creighton University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion rate		1.5 to 2 years	No