Prevalence and Treatment of Anemia in Rehabilitation Patients

This study has been terminated.
(Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated)
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00511901
First received: August 3, 2007
Last updated: December 27, 2013
Last verified: November 2011

August 3, 2007
December 27, 2013
November 2005
May 2008   (final data collection date for primary outcome measure)
Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study [ Time Frame: 8 weeks following randomization ] [ Designated as safety issue: No ]
The primary outcome for this study will be mean hemoglobin concentration at 8 weeks after entry into the study [ Time Frame: 8 weeks following randomization ]
Complete list of historical versions of study NCT00511901 on ClinicalTrials.gov Archive Site
  • Motor-FIM Score [ Time Frame: 3, 8, and 12 weeks following randomization ] [ Designated as safety issue: No ]
    FIM Motor score ranges from 13 to 91 (most independent)
  • Length of Stay in Subacute Rehabilitation Facility [ Time Frame: 12 weeks following randomization ] [ Designated as safety issue: No ]
    Days from randomization to discharge
  • Grip Strength [ Time Frame: 3, 8, and 12 weeks following randomization ] [ Designated as safety issue: No ]
    kilograms measured by hand held dynamometer
  • Short Physical Performance Battery (SPPB) Score [ Time Frame: 3, 8, and 12 weeks following randomization ] [ Designated as safety issue: No ]
    Measure physical function scored 0 - 12 (better)
  • FACIT Measurement System Fatigue Scale [ Time Frame: 3, 8, and 12 weeks following randomization ] [ Designated as safety issue: No ]
    Fatigue score ranges from 0 to 72. Lower score represents less fatigue
  • Activity Counts [ Time Frame: 3, 8, and 12 weeks following randomization ] [ Designated as safety issue: No ]
    Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.
  • POMS Depression-Dejection Scale [ Time Frame: 3,8,12 weeks ] [ Designated as safety issue: No ]
    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).
  • Motor-FIM score [ Time Frame: 3, 8, and 12 weeks following randomization ]
  • Length of stay in subacute rehabilitation facility [ Time Frame: 12 weeks following radomization ]
  • Grip strength [ Time Frame: 3, 8, and 12 weeks following randomization ]
  • Medical Outcome Survey Short Form -36 score [ Time Frame: 3, 8, and 12 weeks following randomization ]
  • Short Physical Performance battery (SPPB) score [ Time Frame: 3, 8, and 12 weeks following randomization ]
  • FACIT Measurement System Fatigue Scale [ Time Frame: 3, 8, and 12 weeks following randomization ]
  • Mini mental status score [ Time Frame: 3, 8, and 12 weeks following randomization ]
  • Activity level as measure by the Acitgraph monitor [ Time Frame: 3, 8, and 12 weeks following randomization ]
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anemia
  • Drug: placebo
  • Drug: epoetin alpha
    Other Name: Procrit
  • Drug: Niferex
    Other Name: iron polysaccharide
  • Placebo Comparator: Placebo & Niferex
    Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
    Interventions:
    • Drug: placebo
    • Drug: Niferex
  • 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
    Interventions:
    • Drug: epoetin alpha
    • Drug: Niferex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00511901
0220045106
Yes
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
Ortho Biotech Clinical Affairs, L.L.C.
Principal Investigator: Jeffrey L Carson, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP