Clinical trial NCT01391182: Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)
Official title: Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Joint Disease
Osteoarthritis
Keywords: Epsilon Aminocaproic Acid
blood loss
total hip arthroplasty
reduction in blood transfusions
Amicar
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Hemoglobin levels and transfusion rates.
timeFrame: 96 hours after total hip arthroplasty surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic Jacksonville, Chair, Orthopedics
name: Mary I O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References: