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

March 23, 2016 updated by: Stanley L Schrier, Stanford University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Red blood cell mass
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma volume measurements
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Stanley L Schrier, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-16209
  • SU-07302009-3480 (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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