Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 11-001111
- Jacksonville, Florida: 11-001111
NCT ID: NCT01391182
Sponsor Protocol Number: 11-001111
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
This study is enrolling participants by invitation only.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mary O'Connor, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Mary O'Connor, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available