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Biomarker Study Protocol WP 09, VHIR-Barcelona

Biomarker Study Protocol WP 09, VHIR-Barcelona . WP 09 - Biomarker Study. OBJECTIVE. Hypothermia proof of concept . Biomarkers analysis. Efficacy. Safety. WP 09 - Biomarker Study. PROTOCOL OVERVIEW. WP 09 - Biomarker Study. MATERIAL. Blood collection. Tube holder*. Serum tubes*.

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Biomarker Study Protocol WP 09, VHIR-Barcelona

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  1. Biomarker Study Protocol WP 09, VHIR-Barcelona Biomarker Study, Protocol Training, v1.0, June 2013

  2. WP 09 - BiomarkerStudy OBJECTIVE Hypothermia proof of concept Biomarkers analysis Efficacy Safety Biomarker Study, Protocol Training, v1.0, June 2013

  3. WP 09 - BiomarkerStudy PROTOCOL OVERVIEW Biomarker Study, Protocol Training, v1.0, June 2013

  4. WP 09 - Biomarker Study MATERIAL Blood collection Tube holder* Serum tubes* Plasma tubes* RNA tube Blood aliquotting Microtubes Pipettes Serum caps Plasma caps DNA caps Biomarker Study, Protocol Training, v1.0, June 2013 *Kindly donated by

  5. WP 09 - Biomarker Study MATERIAL Blood storage Microtube storage RNA storage All the material will be correctly packed and labeled EuroHYP.1 Centre number Patient number 001:001 Sample type Sample time A1 PLASMA Biomarker Study, Protocol Training, v1.0, June 2013

  6. WP 09 - Biomarker Study PROTOCOL Biomarker Study, Protocol Training, v1.0, June 2013

  7. WP 09 - Biomarker Study BLOOD COLLECTION 10 times 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 *Try to avoid hemolysis during blood collection and mixing Immediatly mix the tube by inverting it top-down RNA Serum Plasma REPEAT FOR EACH TUBE Biomarker Study, Protocol Training, v1.0, June 2013

  8. WP 09 - Biomarker Study BLOOD PROCESSING Biomarker Study, Protocol Training, v1.0, June 2013 RNA tube Store in the freezer at -80°C

  9. WP 09 - Biomarker Study BLOOD PROCESSING • Keep in the fridge at 4°C • for at least 30 minutes Serum tubes Plasma tubes Centrifuge at 1500g, 4°C for 15 minutes within 4 hours of blood collection *Try to balance the centrifuge Biomarker Study, Protocol Training, v1.0, June 2013

  10. WP 09 - Biomarker Study BLOOD PROCESSING Serum tubes Plasma tubes Biomarker Study, Protocol Training, v1.0, June 2013

  11. WP 09 - Biomarker Study BLOOD ALIQUOTTING • In the Patient Sample Rack microtubes are distributed according to sample time and sample type Biomarker Study, Protocol Training, v1.0, June 2013

  12. WP 09 - Biomarker Study 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 Biomarker Study, Protocol Training, v1.0, June 2013

  13. WP 09 - Biomarker Study BLOOD ALIQUOTTING Aspirate plasma, aliquot and cap • Transfer to the Sample Storage Rack Biomarker Study, Protocol Training, v1.0, June 2013

  14. WP 09 - Biomarker Study BLOOD ALIQUOTTING Aspirate buffy coat, aliquot and cap • Transfer to the Sample Storage Rack Biomarker Study, Protocol Training, v1.0, June 2013

  15. WP 09 - Biomarker Study SAMPLE STORAGE Sample Storage Rack Store in the freezer at -80°C Biomarker Study, Protocol Training, v1.0, June 2013

  16. WP 09 - Biomarker Study DATA RECORD Complete the eCRF Biomarker Information for the corresponding patient Biomarker Study, Protocol Training, v1.0, June 2013

  17. WP 09 - Biomarker Study DATA RECORD Complete the Sample Data Record sheet Complete Bioimarker Information on the Source Document Biomarker Study, Protocol Training, v1.0, June 2013

  18. WP 09 - Biomarker Study DATA RECORD Obtain and securely store the Patient Informed Consent EuroHYP-1 Biomarker Study Informed Consent Biomarker Study, Protocol Training, v1.0, June 2013

  19. WP 09 - Biomarker Study SAMPLE SHIPMENT RNA Storage Rack Send stored samples to the EuroHYP-1 Biobank at Barcelona Sample Storage Rack Biomarker Study, Protocol Training, v1.0, June 2013

  20. WP 09 - Biomarker Study SAMPLE SHIPMENT Polystyrene box Dry ice Program the shipment wih the Study Coordination and send by way of the Study’s Courier Class 9 label UN1845 label UN3373 label Biomarker Study, Protocol Training, v1.0, June 2013

  21. WP 09 - Biomarker Study SAMPLE SHIPMENT Include important documents Sample Data Record sheet Informed Consent Custody Certificate Biomarker Study, Protocol Training, v1.0, June 2013

  22. WP 09 - Biomarker Study SAMPLE SHIPMENT Include important documents for sample shipment through customs *Non-EU countries Proforma invoice* Biomarker Study, Protocol Training, v1.0, June 2013

  23. WP 09 - Biomarker Study SAMPLE SHIPMENT Record sample shipment on the eCRF Biomarker Study, Protocol Training, v1.0, June 2013

  24. WP 09 - Biomarker Study SAMPLE SHIPMENT Complete the data for shipment registry and management Biomarker Study, Protocol Training, v1.0, June 2013

  25. WP 09 - Biomarker Study SAMPLE SHIPMENT Ask for more Patient Sample Material Biomarker Study, Protocol Training, v1.0, June 2013

  26. WP 09 - Biomarker Study SAMPLE SHIPMENT Complete the form for material consignment Biomarker Study, Protocol Training, v1.0, June 2013

  27. WP 09 - Biomarker Study 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 info.lin.bcn@gmail.com Neurovascular Research LaboratoryValld’Hebrón Research Institute Mediterrania BuildingPg. Valld’Hebrón, 119-129 08035 Barcelona Phone: +34 93 489 40 29Fax:     +34 93 489 40 15 Biomarker Study, Protocol Training, v1.0, June 2013

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