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

Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Degenerative Joint Disease; Osteoarthritis

Intervention: EACA (Other); Placebo arm (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Mary I O'Connor, MD, Principal Investigator, Affiliation: Mayo Clinic Jacksonville, Chair, Orthopedics

Overall contact:
Mary I O'Connor, MD, Phone: 9049532496, Email: oconnor.mary@mayo.edu

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.

Clinical Details

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

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

Primary outcome: Hemoglobin levels and transfusion rates.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mary I O'Connor, MD, Phone: 9049532496, Email: oconnor.mary@mayo.edu

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States; Recruiting
Mary I O'Connor, MD, Phone: 904-953-2496, Email: oconnor.mary@mayo.edu
Shari S Kazmerchak, BSN, Phone: 9049532496, Email: kazmerchak.shari@mayo.edu
Kurt E Blasser, MD, Sub-Investigator
Mark P Brodersen, MD, Sub-Investigator
Mary I O'Connor, MD, Principal Investigator
Klaus D Torp, MD, Sub-Investigator
Joel A Tucker, MD, Sub-Investigator
Kenneth Kaminski, MD, Sub-Investigator
Additional Information

Starting date: July 2011
Last updated: September 27, 2011

Page last updated: December 08, 2011

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