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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391182

Enrollment

Registered

2011-07-11

Start date

2011-07-31

Completion date

2015-01-31

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Joint Disease, Osteoarthritis

Keywords

Epsilon Aminocaproic Acid, blood loss, total hip arthroplasty, reduction in blood transfusions, Amicar

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.

Interventions

OTHEREACA

EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

OTHERPlacebo arm

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026