Prevalence and Treatment of Anemia in Rehabilitation Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: placebo; epoetin alpha; Niferex
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: anemia; function; rehabilitation

Summary:

      Patients who are admitted to subacute rehabilitation facilities following hospitalization are
      frequently anemic. The purpose of this study is to see if anemic patients treated with
      epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and
      12 weeks after study entry compared to patients who do not receive epoetin alfa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  Admission hemoglobin concentration of < 10.5 g/dL.

          -  Able to read and understand English.

          -  Consent signed by subjects.

        Exclusion Criteria:

          -  Unable to randomize within 7 days of admission to rehabilitation center.

          -  Folstein min-mental status score of < 21.

          -  Neuromuscular disease and/or disability; in clinical judgment of the investigators
             that do not have rehabilitation potential.

          -  Diagnosis or evidence of carcinoma (excluding skin cancer other than melanoma) within
             the past five years

          -  Admission for stroke with residual deficit

          -  Wheelchair bound prior to acute event.

          -  Dialysis dependent chronic renal failure

          -  Home more than 1 hour drive from hospital.

          -  Admitted to long term nursing or hospice care.

          -  Active blood loss.

          -  Known history of severe iron deficiency.

          -  Hematological disease that results in anemia that may not respond to erythropoietin
             (including, but not limited to, myelodysplastic syndrome, hematological malignancy,
             hemolytic syndromes, hemoglobinopathy).

          -  Uncontrolled hypertension (systolic BP >200 mmHg or diastolic BP >110 mmHg) after
             adequate antihypertensive therapy.

          -  New onset seizures (within three months) or seizures not controlled by medication.

          -  Objective diagnosis of pulmonary embolism or deep vein thrombosis within the past 10
             years.

          -  Patients with a condition (e.g. psychiatric illness) or in a situation that, in the
             investigator's opinion, may put the subject at significant risk, may confound the
             study results, or may interfere significantly with the subject's compliance with study
             procedures.

          -  Acute burns.

          -  Treatment with any recombinant human erythropoietin within 30 days prior to
             enrollment.

          -  Known hypersensitivity to human albumin or mammalian cell-derived products or
             recombinant human erythropoietin (rHuEPO).

          -  Received an experimental drug or used an experimental medical device within 30 days
             prior to the planned start of treatment.

          -  Pregnancy or lactation.

          -  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.