Thrombocytopenia Clinical Trial
Official title:
PRESS Pathogen Reduction Extended Storage Study PRESS (Pathogen Reduction Extended Storage Study) A Pilot Study of Mirasol Platelets Treated in Platelet Additive Solution in Thrombocytopenic Patients
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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