Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00210626

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

192

Starts

2005-08-01

Expected to finish

2008-06-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Orange, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Denver, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Maywood, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — El Paso, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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