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
Recombinant Human Erythropoietin (R-HuEPO) in Non-Anemic Patients Scheduled for Orthopedic or Cardiovascular Surgery, to Facilitate Presurgical Autologous Blood Donation (A Double-blind, Randomized, Dose Finding Study)
1 other identifier
interventional
80
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 1990
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1990
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 1992
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedMay 18, 2011
February 1, 2011
December 22, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Secondary Outcomes (1)
Changes in safety parameters (laboratory tests, vital signs, physical examination, and adverse events) from before the study to the end of the study
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
January 1, 1990
Study Completion
May 1, 1992
Last Updated
May 18, 2011
Record last verified: 2011-02