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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Degenerative Joint Disease
• Intervention / Treatment: Other: EACA; Other: Placebo arm

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin levels and transfusion rates.	Postoperative hemogloblins will be monitored on postop day 1, 2, and 3.	96 hours after total hip arthroplasty surgery.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mary I O'Connor, MD, Mayo Clinic Jacksonville, Chair, Orthopedics

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: blood loss; total hip arthroplasty; Epsilon Aminocaproic Acid; reduction in blood transfusions; Amicar
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Hemorrhage; Joint Diseases
• Other Study ID Numbers: 11-001111