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Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mary O'Connor, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01391182
First received: July 7, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

You are being asked to take part in this research study because you are scheduled to have total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA to prevent bleeding during and after surgery; use of this drug as a means of preventing bleeding is not currently approved by the FDA.


Condition Intervention
Degenerative Joint Disease
Osteoarthritis
 Other: EACA
Other: Placebo arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Hemoglobin levels and transfusion rates. [ Time Frame: 96 hours after total hip arthroplasty surgery. ] [ Designated as safety issue: Yes ]
    Postoperative hemogloblins will be monitored on postop day 1, 2, and 3.


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EACA arm
In order to obtain sufficient power, a total of 120 patients will be studied, 60 in each group. The surgeon performing the case, their staff, the anesthesiologist, nurse anesthetist and the patient will be blinded to whether the patient received EACA or placebo. Pharmacy will prepare the EACA dose or the saline. Serum hemoglobin levels with be drawn preoperatively and on post operative days one, two, and three. The first dose will be given in the operating room prior to incision (within 30 minutes of the incision). The second dose will be given four hours after the first dose. Two doses are given due to the short half-life of EACA. The timing of administration of EACA will be recorded.
 Other: EACA
EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.
Placebo Comparator: Placebo arm
In order to obtain sufficient power, a total of 120 patients will be studied, 60 in each group. The surgeon performing the case, their staff, the anesthesiologist, nurse anesthetist and the patient will be blinded to whether the patient received EACA or placebo. Pharmacy will prepare the EACA dose or the saline. Serum hemoglobin levels with be drawn preoperatively and on post operative days one, two, and three. The first dose will be given in the operating room prior to incision (within 30 minutes of the incision). The second dose will be given four hours after the first dose. Two doses are given due to the short half-life of EACA. The timing of administration of EACA will be recorded.
 Other: Placebo arm
Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

Detailed Description:

The goal of this prospective randomized study is to evaluate the effectiveness of a drug, epsilon aminocaproic acid (EACA), in reducing the frequency of postoperative blood transfusion following primary total hip arthroplasty. In our institution, up to 40% of patients with a preoperative of 13.5 g/dl or less undergoing total hip arthroplasty will require a blood transfusion. Fibrinolytic drugs such as EACA and tranexamic acid (TA) have been shown to decrease blood loss during surgery and decrease the likelihood of blood transfusion during postoperative hospitalization.. Both drugs decrease the body's ability to break down a blood clot, thus pushing the balance of blood clot formation and breakdown towards clot formation. This mechanism can decrease the amount of blood loss during and after a surgical procedure. The haemostatic effect of EACA has been investigated in multiple studies with the majority showing a positive effect on postoperative hemoglobin levels and decreased blood transfusion rates. Though several studies exist revealing the effective and safe use of perioperative TA, a similar drug to EACA, there is a paucity of information on the use of EACA in total joint arthroplasty.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Scheduled for a primary total hip arthroplasty to be performed at the Mayo Clinic
  2. A preoperative hemoglobin between 10.0 and 13.5

Exclusion Criteria:

  1. A preoperative hemoglobin less than 10.0 or greater than 13.5
  2. Revision arthroplasty;
  3. Arthroplasty performed for acute fracture
  4. Inability to obtain informed consent;
  5. Allergy to EACA
  6. Pregnancy
  7. History of coronary stenting < 6 months
  8. Heart valve replacement;
  9. Renal disease,
  10. Coagulopathy, DIC,
  11. embolic stroke
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391182

Locations
United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85259
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mary I O'Connor, MD Mayo Clinic Jacksonville, Chair, Orthopedics
  More Information

No publications provided

Responsible Party: Mary O'Connor, Chair, Department of Orthopedic Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01391182     History of Changes
Other Study ID Numbers: 11-001111
Study First Received: July 7, 2011
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Epsilon Aminocaproic Acid
blood loss
total hip arthroplasty
reduction in blood transfusions
Amicar

Additional relevant MeSH terms:
Hemorrhage
Joint Diseases
Osteoarthritis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
6-Aminocaproic 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 May 22, 2013