Anemia in the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University
ClinicalTrials.gov Identifier:
NCT00640172
First received: March 6, 2008
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus additional laboratory tests to determine the etiology of the anemia. In a subset of subjects, bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid progenitor and stem cells. Plasma; serum; and bone marrow samples will be will be compared to elderly non-anemic controls. Bone marrow samples will also be compared to non-anemic young controls (purchased).

Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anemia in the Elderly

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA
blood, urine and bone marrow

Enrollment: 343
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anemic Elderly
Non-anemic adults (non-elderly, without bone marrow biopsy)
Non-anemic adults (non-elderly, with bone marrow biopsy)
Non-anemic Elderly (control without bone marrow biopsy)
Non-anemic Elderly (control, with bone marrow biopsy)

Detailed Description:
Eligible elderly men and women with anemia will undergo a full hematologic evaluation (blood sample for complete blood count, CBC) to determine the etiology of the anemia (eg, myelodysplastic syndrome). Peripheral smears; iron studies; serum creatinine; serum erythropoietin; reticulocyte count; vitamin B12; and folate levels may be obtained/conducted. When no etiology is identified (ie, "unexplained anemia"), additional laboratory tests will be performed which will include some or all of urinary hepcidin levels; plasma cytokine levels; serum soluble transferrin receptor; C-reactive protein; erythrocyte sedimentation rate; D-Dimer; neopterin level; tryptophan level; and blood for a cytokine profile that may include IL-1, IL-6, TNF-alpha, and VEGF levels. Serum; plasma; and nucleated peripheral blood cells may be banked for future DNA and other analyses. In a subset of those found to have either unexplained anemia (approximately 6 to 30 subjects) or anemia of chronic inflammation (approximately 6 to 30 subjects) , bone marrow aspirate and biopsies may be performed for a planned analysis of erythroid progenitor and stem cells in these populations. In addition, plasma and serum and bone marrow samples will be obtained from elderly non-anemic controls (approximately 6 to 30 subjects), and bone marrow samples will be purchased for non-anemic young controls (approximately 6 to 30 subjects) .
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient elderly men and women (aged 65 years or older) with anemia, and corresponding elderly controls and adult non-elderly controls.
Criteria

INCLUSION CRITERIA: Anemic elderly :

  • Age 65 or older
  • Hemoglobin < 13 g/dL (men) or < 12 g/dL (women) on at least 2 occasions 30 days apart, with the most recent value within at least 14 days of enrollment into the study. In addition, if a CBC is drawn on the date of enrollment, hemoglobin must meet eligibility criteria in order for the patient to enroll.
  • Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System
  • Independent/community living
  • Ability to understand and the willingness to sign a written informed consent document
  • Performance level ECOG 2 or better.

INCLUSION CRITERIA: Non-anemic elderly control, for blood and urine samples, with or without bone marrow biopsy

  • Age 65 or older
  • Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women) within at least 90 days of enrollment into the study
  • Normal white blood cell and platelet counts
  • Independent / community living
  • Ability to understand and the willingness to sign a written informed consent document
  • Performance level ECOG 2 or better
  • Matched to UA population by gender and 10-year age strata (65 to < 75; 75 to < 85; 85 or older).

INCLUSION CRITERIA: Non-anemic adult control (non-elderly), for blood and urine samples, with bone marrow biopsy

  • Age 20 to 35
  • Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women) within at least 90 days of enrollment into the study
  • Normal white blood cell and platelet counts
  • Independent / community living
  • Written informed consent obtained
  • Performance level ECOG 2 or better

Inclusion Criteria: Non-anemic adult control (non-elderly), for blood and urine samples only

  • Age 20 to 64
  • Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women) within at least 90 days of enrollment into the study
  • Normal white blood cell and platelet counts
  • Independent / community living
  • Written informed consent obtained
  • Performance level ECOG 2 or better
  • Will be recruited by the following age strata: 20 to < 35; 35 to < 50; 50 to < 65.

INCLUSION CRITERIA: Non-anemic adult control (non-elderly), with bone marrow biopsy

  • Age 20 to 35
  • Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women)

EXCLUSION CRITERIA: For all groups

  • Substance abuse or mental health or other problems that would make compliance with the protocol unlikely
  • Predicted mortality in less than 3 months, based on co-morbidities
  • Known diagnosis of bone marrow disorder such as

    • Leukemia
    • Metastatic malignancy with bone marrow involvement
    • Myelodysplastic syndrome
    • Monoclonal gammopathy of undetermined significance (MGUS)
  • On any erythropoiesis-stimulating agent in the prior 3 months
  • Having received any red blood cell transfusion in the prior 3 months
  • End stage renal disease as defined by the need for ongoing hemo or peritoneal dialysis
  • Endstage liver disease as defined by the patient¡-s providers in the medical record
  • A medical condition which would make participation risky
  • On any other study requiring ongoing blood or marrow donation which would make additional blood or marrow collection risky to the subject

EXCLUSION CRITERIA: Additional, for healthy controls:

  • History of active malignancy (except non-melanoma skin cancer), or radiation or chemotherapy for treatment of malignancy within the past 24 months
  • HIV positivity
  • Hepatitis B or Hepatitis C positivity
  • Autoimmune disease (including lupus, RA, IBD)
  • Known hematologic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640172

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley L Schrier, MD Stanford University
  More Information

Publications:
Responsible Party: Stanley L Schrier, Professor of Medicine (Hematology), Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00640172     History of Changes
Other Study ID Numbers: IRB-05112  SPO 36101  SU-01082008-967 
Study First Received: March 6, 2008
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 21, 2016