Biomarkers Serum Collection Methodology Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemophilia A

Keywords

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Severe Hemophilia A Hemophilia A Patients Serum collection vs a method of added FVIII to blood samples

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Severe Hemophilia A

Exclusion Criteria

* If they are not diagnosed with severe hemophilia A.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Craig Kessler

IRB

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig Kessler, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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BiomarkersHemA

Identifier Type: -

Identifier Source: org_study_id