Trial | NCT01873768  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    194
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.
Study Started
Jan 31
2014
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Mar 21
2016
Estimate

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.

  • Other names: Cyklokapron

Drug ε-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.

  • Other names: Amicar

Tranexamic acid (TXA) Active Comparator

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) Active Comparator

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.

Criteria 

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
No Results Posted