Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Blood Transfusion
Blood Transfusion, Autologous
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 th...
Detailed Description
Patients undergoing orthopedic or heart and blood vessel surgery frequently require blood transfusions both during and after the operation. Patients often have their own blood collected for this purpo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 1990
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1992
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00270075
Start Date
January 1 1990
End Date
May 1 1992
Last Update
May 18 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.