CompletedPhase 2/3

A Study of the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Undergoing Orthopedic Surgery and Who Have Low Hematocrit Levels (the Percent of Red Blood Cells in Whole Blood)

55 participants

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa and to determine whether epoetin alfa will facilitate self-donation of blood before surgery in patients who have anemia, (as indicated by low hematocrit levels, the percent of red blood cells in whole blood) and who will be undergoing orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients scheduled for hip replacement surgery * having an anticipated requirement of 3 or more units of blood * having a hematocrit level \<=0.39 * having a hemoglobin level \<= 12.5 grams/deciliter * having laboratory tests within normal ranges, including stool negative for occult blood Exclusion Criteria: * Patients with a history of any blood disease * having signs and symptoms of significant disease/dysfunction, or signs and symptoms of significant ongoing blood loss * having uncontrolled high blood pressure, or a folate, vitamin B12, or iron deficiency, or signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment * taking medication known to suppress the formation of red blood cells within 1 month before the start of the study * having a history of seizures, or the presence of active inflammatory disease (e.g., rheumatoid arthritis), however, patients with osteoarthritis may be included in this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of self-donated units of blood and the total volume of red blood cells donated; Number of blood units from other donors used for transfusion during surgery

Trial details

NCT IDNCT00270114

SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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