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Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011361
First Posted: November 11, 2009
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University
  Purpose
On the basis that the clinical consequences of seemingly trivial levels of anemia are surprisingly severe, this study investigates if hemoglobin concentration accurately represents the underlying red cell mass in elderly patients with unresolved anemia.

Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia

Resource links provided by NLM:


Further study details as provided by Stanley L Schrier, Stanford University:

Primary Outcome Measures:
  • Red blood cell mass [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Plasma volume measurements [ Time Frame: 1 day ]

Enrollment: 5
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:
For the study, the routine clinical measurement of hemoglobin will be compared to true red cell mass and plasma volume in elderly patients with anemia.
  Eligibility

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient elderly men and women (aged 65 years or older) with anemia, also enrolled in the "Anemia in the Elderly" NCT00640172 study.
Criteria

INCLUSION CRITERIA:

  • 65 and older
  • Anemia (hemoglobin < 13 g/dL in men or < 12 g/dL in women)
  • Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System

EXCLUSION CRITERIA:

  • Body mass index (BMI):

    • < 18.5 kg/m2
    • > 35 kg/m2
  • Palpable splenomegaly
  • Contraindication to RBC mass/plasma volume testing
  • On any experimental pharmacologic agent in the prior 2 months
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01011361


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley L Schrier, MD Stanford University
  More Information

Responsible Party: Stanley L Schrier, Professor of Medicine (Hematology), Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT01011361     History of Changes
Other Study ID Numbers: IRB-16209
SU-07302009-3480 ( Other Identifier: Stanford University )
First Submitted: November 9, 2009
First Posted: November 11, 2009
Last Update Posted: March 24, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases