Anemia in the Elderly

NCT ID: NCT00640172

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 343 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-12-31

Brief Summary

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).

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) .

Conditions

Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anemic Elderly

No interventions assigned to this group

Non-anemic adults (non-elderly, without bone marrow biopsy)

No interventions assigned to this group

Non-anemic adults (non-elderly, with bone marrow biopsy)

No interventions assigned to this group

Non-anemic Elderly (control without bone marrow biopsy)

No interventions assigned to this group

Non-anemic Elderly (control, with bone marrow biopsy)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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).

• 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

• 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.

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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stanley L Schrier

Professor of Medicine (Hematology), Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanley L Schrier, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University School of Medicine

Stanford, California, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Price EA, Mehra R, Holmes TH, Schrier SL. Anemia in older persons: etiology and evaluation. Blood Cells Mol Dis. 2011 Feb 15;46(2):159-65. doi: 10.1016/j.bcmd.2010.11.004. Epub 2011 Jan 3.

Reference Type: RESULT

PMID: 21208814 (View on PubMed)

Other Identifiers

SPO 36101

Identifier Type: OTHER

Identifier Source: secondary_id

SU-01082008-967

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-05112

Identifier Type: -

Identifier Source: org_study_id