Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia
Recruitment status was Recruiting
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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 |
- 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) |
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 |
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| Contact: Renee Mehra, MS | (650) 736-1836 | ramehra@stanford.edu |
| 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 | |
| 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 May 16, 2013