A Multi-center, Single-blind, Randomized, Parallel, Non Inferiority Study to Separately Investigate the Effect of Standard Platelets Versus Platelets Prepared With Two Commercial Procedures of Pathogen Reduction Technologies (PRT) on Bleeding Incidence and Severity in Thrombocytopenic Recipients
When patient's platelet count, done in early morning every day, falls below
10000/microliter, physician in charge issues a platelet transfusion request to transfusion
service. Transfusion service (which knows patient treatment arm) issues a PRT product or a
standard product as indicated, typically within hours of request receipt; patient's
physician identifies unit code and intended recipient's code and determines vital signs
(pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse
reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the
ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each
enrolled patient and transfers filled forms to data coordinating center in Milan.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
Within 4 weeks after randomization
Yes
Paolo Rebulla, MD
Principal Investigator
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Italy: Ministry of Health
ISS-2007646931
NCT01642563
October 2010
August 2014
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