Clinical trial NCT00511901: Prevalence and Treatment of Anemia in Rehabilitation Patients
Official title: Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Keywords: anemia
function
rehabilitation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Ortho Biotech Clinical Affairs, L.L.C.
First posted: 2007-08-06
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Anemia is associated with loss of function in some studies. However, it is unknown if more rapid correction of anemia in patients who enter a rehabilitation setting after surgery or from hospitalization for acute medical problems leads to shorter rehabilitation stays and improved functional status.

Patients aged 60 and older who have hemoglobin levels of less than 10.5 g/dL will be randomized to receive 8 weekly doses of either erythropoietin alfa or placebo. Functional status will be measured at baseline and then at 3, 8 and 12 weeks.

The following specific aims will be tested in this study:

* Determine the prevalence of anemia in patients admitted to a subacute rehabilitation facility with potential for recovery.
* Determine the baseline functional status of patients admitted to a subacute rehabilitation facility with potential for recovery using the Functional Independence Measure (FIM), an assessment tool used in acute rehabilitation settings.
* Determine if administration of epoetin alfa will result in higher hemoglobin concentrations in patients receiving the drug than in patients given placebo at 3, 8 and 12 weeks after entry into the study.
* Perform a study that establishes the feasibility of a trial to test whether epoetin alfa produces improvements in the FIM, grip strength, the time it takes for patients to reach rehabilitation goals, activity monitor, fatigue, mood, functional recovery and reduces length of rehabilitation stay.

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.

Primary outcomes:
measure: Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study
timeFrame: 8 weeks following randomization
Secondary outcomes:
measure: Motor-FIM Score
timeFrame: 3, 8, and 12 weeks following randomization
measure: Length of Stay in Subacute Rehabilitation Facility
timeFrame: 12 weeks following randomization
measure: Grip Strength
timeFrame: 3, 8, and 12 weeks following randomization
measure: Short Physical Performance Battery (SPPB) Score
timeFrame: 3, 8, and 12 weeks following randomization
measure: FACIT Measurement System Fatigue Scale
timeFrame: 3, 8, and 12 weeks following randomization
measure: Activity Counts
timeFrame: 3, 8, and 12 weeks following randomization
measure: POMS Depression-Dejection Scale
timeFrame: 3,8,12 weeks
Other outcomes:
Locations:
city: Cranbury
country: United States
facility: Elms of Cranbury
state: New Jersey
city: East Brunswick
country: United States
facility: Care One East Brunswick
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Jeffrey L Carson, MD
role: PRINCIPAL_INVESTIGATOR
References: