Research Into the Treatment of Anemia for Critically Ill Patients Admitted to Intensive Care Units (ICU)
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
1 other identifier
interventional
1,460
0 countries
N/A
Brief Summary
Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared with placebo (a liquid without active medicine).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2003
Typical duration for phase_3
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
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 19, 2004
CompletedFirst Posted
Study publicly available on registry
September 21, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJune 8, 2011
April 1, 2010
September 19, 2004
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.
Secondary Outcomes (1)
Cumulative number of units of red blood cell transfusions received from Study Day 1 through Study Day 42, Change in hemoglobin from Study Day 1 through Study Day 29, Mortality through Study Day 29 and Cumulative mortality through Study Day 140.
Interventions
Eligibility Criteria
You may qualify if:
- Critically ill patient admitted to the ICU
- Patient is anemic when entering the study (hemoglobin \</= 12.0 g/dL)
You may not qualify if:
- Patients with a history of blood clots (deep vein thrombosis)
- Patients with acute ischemic cardiac disease
- Patients receiving hemodialysis or peritoneal dialysis
- Patients admitted to the ICU because of acute GI bleeding
- Patients who are planned to be discharged from the ICU within 48 hours of entering the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
PMID: 17804841RESULT
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
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 19, 2004
First Posted
September 21, 2004
Study Start
September 1, 2003
Study Completion
June 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-04