Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier:
NCT01527968
First received: February 3, 2012
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.


Condition Intervention
Osteoarthritis
Drug: Tranexamic Acid
Drug: Epsilon Aminocaproic Acid
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double Blind, Double-Dummy Study Comparing the Safety and Efficacy of Epsilon Aminocaproic Acid (eACA) Versus Tranexamic Acid (TXA) Versus Placebo for Prevention of Blood Loss in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Heekin Orthopedic Research Institute:

Primary Outcome Measures:
  • Blood loss until the drain is removed [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tranexamic Acid
TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
Drug: Tranexamic Acid
TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
Active Comparator: Epsilon Aminocaproic Acid
eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
Drug: Epsilon Aminocaproic Acid
eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
Placebo Comparator: Placebo
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
Drug: Normal Saline
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients scheduled to receive primary unilateral total knee arthroplasty

Exclusion Criteria:

  • Subject requires bilateral staged total knee arthroplasty
  • Religious beliefs that would limit blood transfusion
  • History of acquired defective color vision (inhibits monitoring for adverse events)
  • Patients with a known history of upper urinary tract bleeding
  • History of abnormal coagulation
  • Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery
  • Active intravascular clotting
  • Known allergy to either TXA or eACA
  • Myocardial Infarct within 6 months
  • History of stroke
  • Patient is a prisoner
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527968

Sponsors and Collaborators
Heekin Orthopedic Research Institute
Investigators
Principal Investigator: R. David Heekin, M.D. Heekin Institute for Orthopedic Research
  More Information

No publications provided

Responsible Party: R. David Heekin, Principal Investigator, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier: NCT01527968     History of Changes
Other Study ID Numbers: 242119
Study First Received: February 3, 2012
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Aminocaproic Acid
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014