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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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