Prevalence and Treatment of Anemia in Rehabilitation Patients

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: Ortho Biotech Clinical Affairs, L.L.C.
• Treatments: Epoetin Alfa; Iron

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.