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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391182
• Other study ID #: 11-001111
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: February 25, 2015
• Start date: July 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Hemorrhage
• Joint Diseases
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin levels and transfusion rates.	Postoperative hemogloblins will be monitored on postop day 1, 2, and 3.	96 hours after total hip arthroplasty surgery.	Yes