The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.
1. To evaluate in thrombocytopenic subjects the efficacy and safety of platelets treated with Mirasol Pathogen Reduction Technology (PRT) in Platelet Additive Solution. The following safety and efficacy measures will be compared between Mirasol treated and untreated platelets stored for 2-4 days and stored for 7 days: * Thrombelastography (TEG®) parameters: reaction time R, alpha angle α and maximal amplitude (MA) * Platelet Count Increment and Corrected Count Increment * Time to next platelet transfusion * Incidence of transfusion related (serious) adverse events * Incidence and severity of bleedings 2. To evaluate the use of the TEG® parameters as a measure for platelet transfusion efficacy and to evaluate the correlation between the TEG® parameters and the platelet Corrected Count Increments after platelet transfusions in thrombocytopenic subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
2-4-day-old Mirasol-treated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of \>32% * Cell count \> 800x103/µL
2-4-day-old Untreated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of \>32% * Cell count \> 800x103/µL
Hematology Service Rigshospitalet
Copenhagen, Blegdamsvej, Denmark
Change in Maximum Amplitude at 1-hour Post-transfusion
Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion
Time frame: pre-transfusion, 1-hour post transfusion
Change in Maximum Amplitude at 24-hours Post-transfusion
Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion
Time frame: pre-transfusion, 24-hour post transfusion
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