Anemia in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 3
研究概览
简要总结
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).
详细描述
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) .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 <
- •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
- •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
排除标准
- 未提供
研究者
Stanley L Schrier
Professor of Medicine (Hematology), Emeritus
Stanford University