Red Cell Mass and Plasma Volume Measurements in Elderly M... | NCT01011361

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

NCT01011361

Sponsor

Stanford University

Status

Completed

Last Update Posted

Mar 24, 2016Estimated

Enrollment

5Actual

Phase

Not provided

Conditions

Anemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SU-07302009-3480	Other Identifier	Stanford University

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 9, 2009

First Posted Date

Nov 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2016

Last Update Posted Date

Mar 24, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stanley L Schrier, Professor of Medicine (Hematology), Emeritus, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Measure	Description	Time Frame
Red blood cell mass		1 day

Measure	Description	Time Frame
Plasma volume measurements		1 day

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Outpatient elderly men and women (aged 65 years or older) with anemia, also enrolled in the "Anemia in the Elderly" NCT00640172 study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stanley L Schrier, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided