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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University
ClinicalTrials.gov Identifier:
NCT01011361
First received: November 9, 2009
Last updated: March 23, 2016
Last verified: March 2016
  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 Stanford University:

Primary Outcome Measures:
  • Red blood cell mass [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma volume measurements [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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

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 
Study First Received: November 9, 2009
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on December 02, 2016