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 (CCI1hour) as the primary outcome STUDY DESIGN AND METHODS: A noninferiority RCT was performed where patients with chemotherapy-induced thrombocytopenia (six centers) were randomly allocated to receive PRT-PLTs (Mirasol PRT, Candian-BCT 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 CCI1hour 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). CONCLUSION: 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