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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01391182
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Mary O'Connor, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Degenerative Joint Disease Osteoarthritis Other: EACA Other: Placebo arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)
Study Start Date : July 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: 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.
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 Comparator: 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.
Other: Placebo arm
Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.




Primary Outcome Measures :
  1. Hemoglobin levels and transfusion rates. [ Time Frame: 96 hours after total hip arthroplasty surgery. ]
    Postoperative hemogloblins will be monitored on postop day 1, 2, and 3.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391182


Locations
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United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mary I O'Connor, MD Mayo Clinic Jacksonville, Chair, Orthopedics

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Responsible Party: Mary O'Connor, Chair, Department of Orthopedic Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01391182    
Other Study ID Numbers: 11-001111
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by Mary O'Connor, Mayo Clinic:
Epsilon Aminocaproic Acid
blood loss
total hip arthroplasty
reduction in blood transfusions
Amicar
Additional relevant MeSH terms:
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Aminocaproic Acid
Osteoarthritis
Joint Diseases
Hemorrhage
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants