Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
Condition: Anemia
MeSH terms: Anemia; Critical Illness
Intervention: PROCRIT; Placebo
Intervention description: 40,000 IU/mL/week for max of 12 weeks; 40,000 IU/mL/week for max of 12 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care

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.
    

Eligibility 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