Biomarkers Serum Collection Methodology Study
| Status: | Archived |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | June 2011 |
BIOMARKERS SERUM COLLECTION METHODOLOGY PILOT STUDY
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.
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 ONE 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 PERFORMED IN DUPLICATE ON THE TWO
DIFFERENTLY PROCESSED SERUM SPECIMENS OBTAINED FROM EACH SUBJECT.
RESULTS WILL BE ANALYSED FOR INTER-SUBJECT VARIABILITY USING STORED AGE-MATCHED SAMPLES
PROVIDED BY SYNARC AND INTRA-SUBJECT VARIABILITY WILL ALSO BE ANALYZED.
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