Prevalence and Treatment of Anemia in Rehabilitation Patients
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|ClinicalTrials.gov Identifier: NCT00511901|
Recruitment Status : Terminated (Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated)
First Posted : August 6, 2007
Results First Posted : November 11, 2013
Last Update Posted : January 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: placebo Drug: epoetin alpha Drug: Niferex||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Placebo Comparator: Placebo & Niferex
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
Other Name: 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: epoetin alpha
Other Name: ProcritDrug: Niferex
Other Name: iron polysaccharide
- Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study [ Time Frame: 8 weeks following randomization ]
- Motor-FIM Score [ Time Frame: 3, 8, and 12 weeks following randomization ]FIM Motor score ranges from 13 to 91 (most independent)
- Length of Stay in Subacute Rehabilitation Facility [ Time Frame: 12 weeks following randomization ]Days from randomization to discharge
- Grip Strength [ Time Frame: 3, 8, and 12 weeks following randomization ]kilograms measured by hand held dynamometer
- Short Physical Performance Battery (SPPB) Score [ Time Frame: 3, 8, and 12 weeks following randomization ]Measure physical function scored 0 - 12 (better)
- FACIT Measurement System Fatigue Scale [ Time Frame: 3, 8, and 12 weeks following randomization ]Fatigue score ranges from 0 to 72. Lower score represents less fatigue
- Activity Counts [ Time Frame: 3, 8, and 12 weeks following randomization ]Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.
- POMS Depression-Dejection Scale [ Time Frame: 3,8,12 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511901
|United States, New Jersey|
|Elms of Cranbury|
|Cranbury, New Jersey, United States, 08512|
|Care One East Brunswick|
|East Brunswick, New Jersey, United States, 08816|
|Principal Investigator:||Jeffrey L Carson, MD||Rutgers, The State University of New Jersey|