NCT01368211

Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Terumo BCTbio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	2-4-day-old Mirasol-treated Platelets Transfusion	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
BIOLOGICAL	2-4-day-old Untreated Platelets Transfusion	2-4-day-old Untreated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of \>32% * Cell count \> 800x103/µL

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2011-06-07
• Last updated: 2016-06-28
• Results posted: 2014-04-07

Locations

1 site across 1 country: Denmark