A Study to Evaluate the Safety of Epoetin Alfa and Its Effectiveness in Facilitating the Presurgical Collection of Blood From Anemic Patients for Possible Self-transfusion During and After Scheduled Joint Surgery.
A Double-Blind, Placebo-Controlled Study to Determine Whether R-HuEPO Can Facilitate Presurgical Autologous Blood Donation in Patients With Low Hematocrit Levels
1 other identifier
interventional
77
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety of epoetin alfa and its effectiveness in facilitating the presurgical collection of blood from anemic patients for possible self-transfusion during and after scheduled joint surgery and its effectiveness in reducing surgery-related transfusion requirements. 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 May 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
May 1, 1989
CompletedStudy Completion
Last participant's last visit for all outcomes
July 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 blood self-donated; Number of donor-donated units of blood used; Total red blood cell volume; Total red blood cell production; Change in hemoglobin from baseline to after the final dose of study medication, but before surgery
Secondary Outcomes (1)
Total transfusion requirements at the time of surgery; incidence of adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled for surgery involving the joints, 25 to 35 days after starting epoetin alfa therapy
- having a hematocrit (percentage of red cells in the blood) of \<=39%
- in good general health.
You may not qualify if:
- Patients with a history of any primary blood disease
- having a history of artery blockage in the heart, body or brain, a history of seizures, uncontrolled high blood pressure, or active inflammatory disease, (except osteoarthritis or rheumatoid arthritis)
- losing blood internally from the stomach or intestines or elsewhere in the body
- using of any cell toxic drug, drugs that suppress the immune system, or drugs known to influence red blood cell production (such as chemotherapy for cancer) within 1 month of therapy
- having a folate or vitamin B12 deficiency, iron-deficiency anemia, or a disease that destroys blood cells.
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
May 1, 1989
Study Completion
July 1, 1991
Last Updated
May 18, 2011
Record last verified: 2011-02