A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Facilitating the Presurgical Collection of Blood to be Used for Self-donation During Surgery on the Spine, Hip, or Knee.
A Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of Multiple Doses of R-HuEPO in Facilitating Presurgical Autologous Blood Donation
1 other identifier
interventional
17
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating presurgical collection of blood for self-donation during surgery of the knee, hip or spine. 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 below P25 for phase_3
Started Sep 1989
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1989
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 1991
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 units of units of blood donated by the patient; Number of units of donor blood transfused during surgery; Total red cell volume and percentage in self-donated blood; Percentage of sub-standard units of blood self-donated
Secondary Outcomes (1)
Percentage in each treatment group of patients requiring blood donated by others; Safety evaluations including the incidence of adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled for surgery on the knee, hip, or spine between 25 and 35 days after starting epoetin alfa therapy
- having a hematocrit (percentage of red cells in the blood) of \>39 percent and \<=50 percent
- in good general health
You may not qualify if:
- Patients having a history of any primary blood disease
- having a history of artery blockage in the heart, body or brain, or a history of seizures
- having uncontrolled high blood pressure, a folate deficiency, vitamin B12 deficiency or iron deficiency anemia, active inflammatory disease (except osteoarthritis or rheumatoid arthritis) or a disease that destroys blood cells
- losing blood from the stomach, intestines or elsewhere in the body
- having received therapy with any drug known to affect red blood cell formation (such as chemotherapy for cancer)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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 3
- 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
September 1, 1989
Study Completion
August 1, 1991
Last Updated
May 18, 2011
Record last verified: 2011-02