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Biomarker Study Protocol
WP 09, VHIR-Barcelona
EudraCT-No.: 2012-002944-25
Biomarker Study, Protocol Training, v1.0, June 2013
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WP 09 - Biomarker Study
OBJECTIVE
Hypothermia
proof of concept
Biomarkers analysis
Efficacy
EudraCT-No.: 2012-002944-25
Safety
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PROTOCOL OVERVIEW
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MATERIAL
Blood collection
Tube holder*
Serum tubes* Plasma tubes* RNA tube
Blood aliquotting
Pipettes Microtubes Serum caps
Plasma caps DNA caps
*Kindly donated by
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MATERIAL
Blood storage
Microtube storage
RNA storage
All the material will be correctly packed and labeled
Centre number
Sample time
EudraCT-No.: 2012-002944-25
EuroHYP.1
001:001
A1 PLASMA
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Patient number
Sample type
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PROTOCOL
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BLOOD COLLECTION
Remove the needle cap and
perform the venipuncture
Collect blood pressing the tubes
to the botton of the holder
Take the tube out when
is correctlly filled
10 times
*Try to avoid hemolysis during
blood collection and mixing
Immediatly mix the tube
by inverting it top-down
Serum Plasma RNA
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REPEAT FOR EACH TUBE
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BLOOD PROCESSING
RNA tube
Store in the freezer at -80°C
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BLOOD PROCESSING
Serum tubes Plasma tubes
*Try to balance the centrifuge
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Keep in the fridge at 4°C
for at least 30 minutes
Centrifuge at 1500g, 4°C for 15 minutes
within 4 hours of blood collection
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BLOOD PROCESSING
Serum tubes
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Plasma tubes
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BLOOD ALIQUOTTING
In the Patient Sample Rack
microtubes are distributed
according to sample time and
sample type
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BLOOD ALIQUOTTING
Aspirate serum, aliquot and cap
Transfer to the Sample Storage Rack
*Please do not fill enterely the microtubes
to avoid cap release during freezing
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BLOOD ALIQUOTTING
Aspirate plasma, aliquot and cap
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Transfer to the Sample Storage Rack
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BLOOD ALIQUOTTING
Aspirate buffy coat, aliquot and cap
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Transfer to the Sample Storage Rack
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SAMPLE STORAGE
Sample Storage Rack
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Store in the freezer at -80°C
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DATA RECORD
Complete the eCRF
Biomarker Information for
the corresponding patient
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DATA RECORD
Complete the Sample Data
Record sheet
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Complete Bioimarker Information
on the Source Document
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DATA RECORD
Obtain and securely store the
Patient Informed Consent
EuroHYP-1 Biomarker Study Informed Consent
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SAMPLE SHIPMENT
RNA Storage Rack
Send stored samples to the
EuroHYP-1 Biobank at Barcelona
Sample Storage Rack
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SAMPLE SHIPMENT
Polystyrene box
Class 9 label
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Dry ice
UN1845 label
UN3373 label
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Program the shipment wih the
Study Coordination and send by
way of the Study’s Courier
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SAMPLE SHIPMENT
Include important documents
Sample Data Record sheet
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Informed Consent Custody Certificate
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SAMPLE SHIPMENT
Include important documents for
sample shipment through customs
*Non-EU countries
Proforma invoice*
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SAMPLE SHIPMENT
Record sample shipment on the eCRF
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SAMPLE SHIPMENT
Complete the data for shipment registry and management
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SAMPLE SHIPMENT
Ask for more Patient Sample Material
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SAMPLE SHIPMENT
Complete the form for material consignment
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MORE INFO
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 Laboratory
Vall d’Hebrón Research Institute
Mediterrania Building
Pg. Vall d’Hebrón, 119-129
08035 Barcelona
Phone: +34 93 489 40 29
Fax: +34 93 489 40 15
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