Total Body Albumin Measurement Utilizing a Modification of the BVA 100 Blood Volume Analyzer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542749
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):
Daxor Corporation

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.

Condition or disease
Hypoalbuminemia Heart Failure Nephrosis Cirrhosis Shock

Detailed Description:
Twenty adult individuals underwent a standard blood volume measurement. The specimens for this determination are normally collected over a period of approximately 40 minutes. For the determination of total body albumin, additional specimens were collect over a three to four day period until the counts in the blood specimens were stable. Calculation of the degree of dilution over this time interval is thought to represent dilution of the tracer in albumin in both the intra and extravascular space. The ratio of albumin in the intravascular to the extravascular space is available in the medical literature. The total volume in which the tracer is distributed can be determined from the dilution determined. A calculation of total body albumin is therefore possible. Computation of the total body albumin for the test subjects (all normal individuals) was consistent with values for total body albumin in the literature. The purpose of the development of this method is to permit clinicians to determine albumin status in patients with disturbances in albumin such as burn patients, cirrhotic patients, nephrotic patients as well as patients with protein losing gastroenteropathies.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Research Study to Asses Total Body Albumin Levels
Study Start Date : January 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult male and female volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Children,
  • pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542749

Sponsors and Collaborators
Daxor Corporation
Principal Investigator: Joseph Feldschuh, MD Daxor Corporation

Responsible Party: Daxor Corporation Identifier: NCT01542749     History of Changes
Other Study ID Numbers: DAXOR 01
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: February 2012

Keywords provided by Daxor Corporation:
BVA-100 Blood volume analyzer
Human serum albumin labeled with Iodine 131

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Kidney Diseases
Urologic Diseases