NCT01542749

Brief Summary

The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In addition to calculating human blood volume it is hypothesized that measurement of the dilution of the tracer can also yield an accurate measurement of total body albumin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

February 27, 2012

Last Update Submit

March 1, 2012

Conditions

HypoalbuminemiaHeart FailureNephrosisCirrhosisShock

Keywords

BVA-100 Blood volume analyzerHuman serum albumin labeled with Iodine 131

Outcome Measures

Primary Outcomes (1)

  • Total Body Albumin

    The study demonstrated that total body albumin can be determined utilizing modified software designed for this purpose with the BVA 100 blood volume analyzer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult male and female volunteers

You may qualify if:

  • Normal adult males and females.
  • Females in the childbearing age group to have test to exclude pregnancy

You may not qualify if:

  • Children,
  • pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypoalbuminemiaHeart FailureNephrosisFibrosisShock

Condition Hierarchy (Ancestors)

HypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHeart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Feldschuh, MD

    Daxor Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

January 1, 2009

Primary Completion

August 1, 2010

Study Completion

January 1, 2012

Last Updated

March 2, 2012

Record last verified: 2012-02