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Completed

NCT Number: NCT01391182

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EACA

Other

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

Placebo arm

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2011
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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