GFI-Item5-CPP_Phase_2_Protocol-Dated_10Feb2018_Pages_1-40.pdf

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Cryopreserved Platelet (CPP) Development for U. S. Food and Drug Administration Licensure
Solicitation number
W81XWH19R0033
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Solicitation W81XWH19R0033 Government Furnished Information - Item 5 CPP Phase 2 Protocol Part 1 of 2

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Contamination of apheresis platelets

Leukoreduction during apheresis platelet collection.

Transfusion of blood components

Unintended thrombosis and thrombotic events associated with increased levels of pro-coagulation parameters associated with platelet cryopreservation sis and thromboticis and thrombotic parameters associaarameters associa ad hoc

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