Status:
TERMINATED
Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to evaluate the physical function outcomes in anemic, critically ill, trauma subjects treated with epoetin alfa (PROCRIT®) compared to placebo.
Detailed Description
The overall study design is based on the assumption that the maximum increase in red blood cells and their effect often does not occur while a subject is in the ICU and acutely ill. The study hypothes...
Eligibility Criteria
Inclusion
- ICU admission secondary to a blunt multi-system traumatic injury
- A leg or pelvic fracture must be one of the injuries sustained
- Male or female
- Age between 18 and 55 years
- Hemoglobin \<=12g/dL at study entry
- An expected ICU stay \>=2 days
- Glascow Coma Scale (GCS) score must be \>= 13 at hospital admission or within 24 hours of admission
- Documented ability to function independently prior to this hospitalization as determined by a subject or proxy interview using the Karnofsky Performance scale and having a score \>=80
- Subjects (or appropriate legal representative) must sign the informed consent form after the nature of the study has been fully explained
- Female subjects that can become pregnant must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during study
- Subjects must be literate in their native language in order to complete written self-assessments during the post-hospital discharge phase
Exclusion
- Acute burns
- Traumatic Brain Injury (TBI) with admission GCS \<= 12 and/or spinal cord injury
- Cause of injury secondary to a fall from a standing position
- Trauma victims transferred into the participating institution \> 8 hours post injury
- Subjects not expected to survive 12 months given their injuries and/or pre-existing, uncorrectable medical condition
- Chronic renal failure on dialysis
- Significant hematological disease
- All subjects expected to undergo chemotherapy during the course of treatment
- A current diagnosis of uncontrolled hypertension
- New onset seizures (within three months) or seizures not controlled by medication prior to admission
- Gustillo III fracture, open pelvic fracture, traumatic amputation
- Prior history or diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or genetic coagulation abnormality
- Pregnancy or lactation
- Refusal to accept blood transfusion
- Received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment
- Treatment with any recombinant human erythropoietin within 30 days prior to enrollment - Known hypersensitivity to human albumin or mammalian cell-derived products or epoetin alfa
- Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00210626
Start Date
August 1 2005
End Date
June 1 2008
Last Update
April 21 2014
Active Locations (21)
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1
Birmingham, Alabama, United States
2
Orange, California, United States
3
Santa Barbara, California, United States
4
Denver, Colorado, United States