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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
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01011361
First received: November 9, 2009
Last updated: January 29, 2010
Last verified: January 2010
  Purpose

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.


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 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.

  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011361

Contacts
Contact: Renee Mehra, MS (650) 736-1836 ramehra@stanford.edu

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

No publications provided

Responsible Party: Stanley L Schrier, Stanford University School of Medicine
ClinicalTrials.gov 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:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014