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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011361
• Other study ID #: IRB-16209
• Secondary ID: SU-07302009-3480
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: March 23, 2016
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: March 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell mass		1 day	No
Secondary	Plasma volume measurements		1 day	No