A Study to Determine the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation o… (NCT00270075) | Clinical Trial Compass
CompletedPhase 2/3
A Study to Determine the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Not Anemic and Who Will be Undergoing Orthopedic or Heart and Blood Vessel Surgery
80 participantsStarted 1990-01
Plain-language summary
The purpose of this study is to determine whether epoetin alfa will enable self-donation of at least 4 units of blood during the 2-week period before surgery (which is a shorter period of time than the conventional 3-week blood donation period before surgery) in patients who are not anemic and who will be undergoing orthopedic or heart and blood vessel 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 orthopedic or heart and blood vessel surgery
* requirement of 3 or more units of blood
* who are non-anemic (hemoglobin within normal range of 12.0 - 18.0 grams/deciliter)
* having laboratory tests within normal ranges
Exclusion Criteria:
* Patients with history of any primary blood disease
* having signs and symptoms of significant disease/dysfunction, such as signs and symptoms of significant heart and blood vessel disease (in patients undergoing orthopedic surgery) or severe alteration in rhythm of the heartbeat, persistent brief attacks of chest pain, or significant heart failure in which the heart is unable to maintain adequate circulation of blood (in patients undergoing heart and blood vessel surgery)
* having uncontrolled high blood pressure or signs and symptoms of significant dizziness, faintness, or lightheadedness which appear only on standing and are caused by low blood pressure
* who have received a blood transfusion within 1 month before the start of the study
* having a body weight greater than 100 kilograms (approximately 220 pounds)
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
1
Number of self-donated units of blood collected within 2 weeks; Change in hemoglobin level from before the start of the study to the end of the study
Trial details
NCT IDNCT00270075
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.