Prevalence and Treatment of Anemia in Rehabilitation Patients

Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital

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.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: placebo; Drug: Niferex; Drug: epoetin alpha

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Cranbury, New Jersey, United States, 08512
      • Elms of Cranbury
    • East Brunswick, New Jersey, United States, 08816
      • Care One East Brunswick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo & Niferex; Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks	Drug: placebo; Drug: Niferex; Other Names: iron polysaccharide
Active Comparator: epoetin alpha & Niferex; 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks	Drug: Niferex; Other Names: iron polysaccharide; Drug: epoetin alpha; Other Names: Procrit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study	8 weeks following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor-FIM Score	FIM Motor score ranges from 13 to 91 (most independent)	3, 8, and 12 weeks following randomization
Length of Stay in Subacute Rehabilitation Facility	Days from randomization to discharge	12 weeks following randomization
Grip Strength	kilograms measured by hand held dynamometer	3, 8, and 12 weeks following randomization
Short Physical Performance Battery (SPPB) Score	Measure physical function scored 0 - 12 (better)	3, 8, and 12 weeks following randomization
FACIT Measurement System Fatigue Scale	Fatigue score ranges from 0 to 72. Lower score represents less fatigue	3, 8, and 12 weeks following randomization
Activity Counts	Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.	3, 8, and 12 weeks following randomization
POMS Depression-Dejection Scale	Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).	3,8,12 weeks

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: Ortho Biotech Clinical Affairs, L.L.C.
• Investigators: Principal Investigator: Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 3, 2007
• First Submitted That Met QC Criteria: August 3, 2007
• First Posted (Estimate): August 6, 2007

Study Record Updates

• Last Update Posted (Estimate): January 31, 2014
• Last Update Submitted That Met QC Criteria: December 27, 2013
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: rehabilitation; anemia; function
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: 0220045106