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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Joint Disease, Osteoarthritis

Intervention / Treatment
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* Other: EACA
* Other: Placebo arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for a primary total hip arthroplasty to be performed at the Mayo Clinic A preoperative hemoglobin between 10.0 and 13.5 Exclusion Criteria: A preoperative hemoglobin less than 10.0 or greater than 13.5 Revision arthroplasty; Arthroplasty performed for acute fracture Inability to obtain informed consent; Allergy to EACA Pregnancy History of coronary stenting < 6 months Heart valve replacement; Renal disease, Coagulopathy, DIC, embolic stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EACA arm<br>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<br>* EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.<br>|
| Placebo Comparator: Placebo arm<br>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<br>* Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epsilon Aminocaproic Acid, blood loss, total hip arthroplasty, reduction in blood transfusions, Amicar