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Biomarkers Serum Collection Methodology Pilot Study

Biomarkers Serum Collection Methodology Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01318707
Enrollment
20
Registered
2011-03-18
Start date
2010-12-31
Completion date
2011-05-31
Last updated
2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

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

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Georgetown University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Severe Hemophilia A

Exclusion criteria

* If they are not diagnosed with severe hemophilia A.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026