Anemia in the Elderly

Anemia Clinical Trial

Official title:

Anemia in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640172
• Other study ID #: IRB-05112
• Secondary ID: SPO 36101SU-0108
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: March 23, 2016
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation