Biomarker Study ProtocolWP 09, VHIR-Barcelona
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Biomarker Study, Protocol Training, v1.0, June 2013
WP 09 - Biomarker StudyOBJECTIVE
Hypothermiaproof of concept
Efficacy
Safety
Biomarkers analysis
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WP 09 - Biomarker StudyPROTOCOL OVERVIEW
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Tube holder* Serum tubes* Plasma tubes* RNA tube
Pipettes Serum caps Plasma caps DNA caps
Blood collection
Blood aliquotting
*Kindly donated by
Microtubes
WP 09 - Biomarker StudyMATERIAL
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Microtube storage RNA storage
Blood storage
EuroHYP.1001:001
A1 PLASMAPatient numberCentre number
Sample typeSample time
All the material will be correctly packed and labeled
WP 09 - Biomarker StudyMATERIAL
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WP 09 - Biomarker StudyPROTOCOL
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Remove the needle cap andperform the venipuncture
10 times
Immediatly mix the tube by inverting it top-down
Collect blood pressing the tubes to the botton of the holder
Take the tube out whenis correctlly filled
REPEAT FOR EACH TUBERNA PlasmaSerum
*Try to avoid hemolysis during blood collection and mixing
WP 09 - Biomarker StudyBLOOD COLLECTION
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WP 09 - Biomarker StudyBLOOD PROCESSING
Store in the freezer at -80°C
RNA tube
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Centrifuge at 1500g, 4°C for 15 minutes within 4 hours of blood collection
Serum tubesKeep in the fridge at 4°C
for at least 30 minutesPlasma tubes
*Try to balance the centrifuge
WP 09 - Biomarker StudyBLOOD PROCESSING
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Serum tubes Plasma tubes
WP 09 - Biomarker StudyBLOOD PROCESSING
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In the Patient Sample Rack microtubes are distributed
according to sample time and sample type
WP 09 - Biomarker StudyBLOOD ALIQUOTTING
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WP 09 - Biomarker StudyBLOOD ALIQUOTTING
Aspirate serum, aliquot and cap
*Please do not fill enterely the microtubes to avoid cap release during
freezing
Transfer to the Sample Storage Rack
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Aspirate plasma, aliquot and cap Transfer to the Sample Storage Rack
WP 09 - Biomarker StudyBLOOD ALIQUOTTING
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WP 09 - Biomarker StudyBLOOD ALIQUOTTING
Aspirate buffy coat, aliquot and cap Transfer to the Sample Storage Rack
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WP 09 - Biomarker StudySAMPLE STORAGE
Store in the freezer at -80°CSample Storage Rack
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Complete the eCRF Biomarker Information for the corresponding patient
WP 09 - Biomarker StudyDATA RECORD
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WP 09 - Biomarker StudyDATA RECORD
Complete the Sample Data Record sheet
Complete Bioimarker Information on the Source Document
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WP 09 - Biomarker StudyDATA RECORD
Obtain and securely store the Patient Informed Consent
EuroHYP-1 Biomarker Study Informed Consent
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Send stored samples to the EuroHYP-1 Biobank at Barcelona
RNA Storage Rack
Sample Storage Rack
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Program the shipment wih the Study Coordination and send by
way of the Study’s Courier
Polystyrene box Dry ice
Class 9 label UN1845 label UN3373 label
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Sample Data Record sheet Informed Consent Custody Certificate
Include important documents
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WP 09 - Biomarker StudySAMPLE SHIPMENT
*Non-EU countries
Include important documents for sample shipment through customs
Proforma invoice*
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Record sample shipment on the eCRF
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Complete the data for shipment registry and management
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Ask for more Patient Sample Material
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WP 09 - Biomarker StudySAMPLE SHIPMENT
Complete the form for material consignment
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Written and Video versions of the Biomarker Protocol will be available at:
— EuroHYP-1 Training Portal— Milliarium Platform → Documents → SOPs— http://goo.gl/XpCfx
For further information regarding the Biomarker Study please contact Biomarker Study Coordination at [email protected]
Neurovascular Research LaboratoryVall d’Hebrón Research Institute
Mediterrania BuildingPg. Vall d’Hebrón, 119-129
08035 Barcelona
Phone: +34 93 489 40 29Fax: +34 93 489 40 15
WP 09 - Biomarker StudyMORE INFO
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