NCT01011361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

November 9, 2009

Last Update Submit

March 23, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Red blood cell mass

    1 day

Secondary Outcomes (1)

  • Plasma volume measurements

    1 day

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Stanley L Schrier, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine (Hematology), Emeritus

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 24, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)