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NCT01318707 Clinical Trial

Biomarkers Serum Collection Methodology Pilot Study

Hemophilia A Clinical Trial

Official title:
Biomarkers Serum Collection Methodology Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01318707
Other study ID # BiomarkersHemA
Secondary ID
Status Completed
Phase N/A
First received December 16, 2010
Last updated July 23, 2012
Start date December 2010
Est. completion date May 2011

Study information
Verified date July 2012
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added FVIII to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

Description:

20 adults with severe Hemophilia A seen in one HTC site for routine blood drawing will be consented for discard blood sampling.

Half of the whole blood discard will be placed in a tiger top test tube, and half of the whole blood discard sample will be placed in a red top test tube containing exogenously added recombinant human FVIII concentrate [Advate, Baxter immuno] to assure an end concentration of once IU per CC of whole blood.

Both whole blood specimens will be allowed to coagulate at room temperature and then will be centrifuged to prepare serum. The separated serum from each type of collection test tubes will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of 150 microliters. Aliquoted serum samples will be stored at -70 degrees centigrade and shipped on dry ice to Synarc Labs.

A panel of standard CTX bone resorption assays will be preformed in duplicate on the two differently processed serum specimens obtained from each subject.

Results will be analyzed for inter-subject variability using stored age-matched samples provided by Synarc and intra-subject variability will also be analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Severe Hemophilia A

Exclusion Criteria:

- If they are not diagnosed with severe hemophilia A.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Lombardi Cancer Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

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