A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology.
BACKGROUND
Pathogen reduction of platelets (PRT-PLTs) using riboflavin and ultraviolet light treatment has undergone Phase 1 and 2 studies examining efficacy and safety. This randomized controlled clinical trial (RCT) assessed the efficacy and safety of PRT-PLTs using the 1-hour corrected count increment (CCI(1hour) ) as the primary outcome.


METHODS
A noninferiority RCT was performed where patients with chemotherapy-induced thrombocytopenia (six centers) were randomly allocated to receive PRT-PLTs (Mirasol PRT, CaridianBCT Biotechnologies) or reference platelet (PLT) products. The treatment period was 28 days followed by a 28-day follow-up (safety) period. The primary outcome was the CCI(1hour) determined using up to the first eight on-protocol PLT transfusions given during the treatment period.


RESULTS
A total of 118 patients were randomly assigned (60 to PRT-PLTs; 58 to reference). Four patients per group did not require PLT transfusions leaving 110 patients in the analysis (56 PRT-PLTs; 54 reference). A total of 541 on-protocol PLT transfusions were given (303 PRT-PLTs; 238 reference). The least square mean CCI was 11,725 (standard error [SE], 1.140) for PRT-PLTs and 16,939 (SE, 1.149) for the reference group (difference, -5214; 95% confidence interval, -7542 to -2887; p<0.0001 for a test of the null hypothesis of no difference between the two groups).


CONCLUSIONS
The study failed to show noninferiority of PRT-PLTs based on predefined CCI criteria. PLT and red blood cell utilization in the two groups was not significantly different suggesting that the slightly lower CCIs (PRT-PLTs) did not increase blood product utilization. Safety data showed similar findings in the two groups. Further studies are required to determine if the lower CCI observed with PRT-PLTs translates into an increased risk of bleeding.
D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000517:prevention & control*; D001792:Blood Platelets / Q000187:drug effects / Q000528:radiation effects; D001793:Blood Preservation / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D019337:Hematologic Neoplasms / Q000150:complications; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion / Q000009:adverse effects / Q000379:methods*; D012256:Riboflavin / Q000009:adverse effects / Q000494:pharmacology*; D013921:Thrombocytopenia / Q000209:etiology / Q000628:therapy*; D016896:Treatment Outcome; D014466:Ultraviolet Rays; D055815:Young Adult
D012256:Riboflavin