A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.
A Double-Blind, Placebo-Controlled Study to Determine the Safety of r-HuEPO and Whether r-HuEPO Can Reduce Post-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery
1 other identifier
interventional
1
0 countries
N/A
Brief Summary
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic 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 below P25 for phase_2
Started Apr 1991
Shorter than P25 for phase_2
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
April 1, 1991
CompletedStudy Completion
Last participant's last visit for all outcomes
October 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
November 1, 2010
December 22, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study
Secondary Outcomes (1)
Adverse events; Changes in clinical laboratory test results, vital signs, and physical examination findings
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled for major orthopedic surgery who are expected to require transfusion of at least 2 units of red blood cells
- who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
- having no significantly abnormal blood or urine test results
- having a hematocrit \<= 45%
You may not qualify if:
- Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction
- having signs and symptoms of significant and ongoing blood loss
- having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug
- received medication known to suppress the formation of red blood cells within 1 month before the start of the study
- received a blood transfusion within 1 month before the start of the study
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 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
April 1, 1991
Study Completion
October 1, 1991
Last Updated
May 18, 2011
Record last verified: 2010-11