biomarker study protocol wp 09, vhir-barcelona

Biomarker Study ProtocolWP 09, VHIR-Barcelona

EudraCT-No.: 2012-002944-25 Biomarker Study, Protocol Training, v1.0, June 2013 26 slides

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


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Serum tubes Plasma tubes


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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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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


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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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Complete the Sample Data Record sheet

Complete Bioimarker Information on the Source Document

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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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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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Sample Data Record sheet Informed Consent Custody Certificate

Include important documents

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*Non-EU countries

Include important documents for sample shipment through customs

Proforma invoice*

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Record sample shipment on the eCRF

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Complete the data for shipment registry and management

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Ask for more Patient Sample Material

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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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http://goo.gl/XpCfx

mailto:[email protected]

biomarker study protocol wp 09, vhir-barcelona

Documents

protocol training

study coordination

different blood tubes

sample collection

time blood collection

blood samples

blood processing

slidesthis protocol