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

NCT ID: NCT01391182

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Degenerative Joint Disease; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EACA

Intervention Type: OTHER

EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

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.

Group Type: PLACEBO_COMPARATOR

Placebo arm

Intervention Type: OTHER

Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

Interventions

EACA

EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

Intervention Type: OTHER

Placebo arm

Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mary O'Connor

Chair, Department of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary I O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Jacksonville, Chair, Orthopedics

Locations

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

11-001111

Identifier Type: -

Identifier Source: org_study_id