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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Stanford University.
Recruitment status was  Recruiting
Information provided by:
Stanford University Identifier:
First received: November 9, 2009
Last updated: January 29, 2010
Last verified: January 2010
The question of whether the hemoglobin concentration itself accurately represents the underlying red cell mass in elderly patients with anemia has not previously been addressed. This question has arisen because the clinical consequences of seemingly trivial levels of anemia are surprisingly severe. We wish to test this hypothesis by measuring the true red cell mass and plasma volume in elderly with anemia and compare this value with the routine clinical measurement of hemoglobin.


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 Stanford University:

Primary Outcome Measures:
  • red blood cell mass [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • plasma volume measurements [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Patients will be enrolled from the "Anemia in the Elderly" study and thus will already have had a full hematologic evaluation for their anemia. They will have a complete blood count as part of this evaluation. After enrolling, they will have red blood cell mass and plasma volume measurements performed either at California Pacific Medical Center (CPMC) as per standard clinical practice or at Stanford Hospital and Clinics if this test becomes available at Stanford. We are in discussions with Dr. Michael Goris from Nuclear Medicine re: the possibility of having this test available here at Stanford. Tests will be scheduled as routine clinical tests at this institution (requiring approximately 2 weeks scheduling time). Red blood cell mass will be measured from the dilution of chromium-51 (51 Cr) labeled autologous fresh RBCs in the patient's blood volume. The plasma volume will be measured with labeled albumin.

On the same day as these tests, subjects will also give a blood sample (10 cc) for the following tests: complete blood count (CBC), spun hematocrit and serum erythropoietin level. They will also have their height and weight measured.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be outpatients at either the VAPAHCS or SHC, who will be enrolled from the "Anemia in the Elderly" study.

Inclusion Criteria:65 and older Anemia (hb < 12 g/dL in women, < 13 g/dL in men) Outpatient at either the VAPAHCS or SHC

Exclusion Criteria:BMI (kg/m2) < 18.5 and > 35 Palpable splenomegaly Contraindication to RBC mass/plasma volume testing On any experimental pharmacologic agent in the prior 2 months

  Contacts and Locations
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Please refer to this study by its identifier: NCT01011361

Contact: Renee Mehra, MS (650) 736-1836

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Renee Mehra, MS    650-736-1836   
Principal Investigator: Stanley L Schrier         
Sub-Investigator: Elizabeth Price         
Sponsors and Collaborators
Stanford University
Principal Investigator: Stanley L Schrier Stanford University
  More Information

No publications provided

Responsible Party: Stanley L Schrier, Stanford University School of Medicine Identifier: NCT01011361     History of Changes
Other Study ID Numbers: SU-07302009-3480 
Study First Received: November 9, 2009
Last Updated: January 29, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Diseases processed this record on February 07, 2016