A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology Academic Article uri icon

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  • 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. 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, 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). 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.


  • Cazenave, J-P
  • Folléa, G
  • Bardiaux, L
  • Boiron, J-M
  • Lafeuillade, B
  • Debost, M
  • Lioure, B
  • Harousseau, J-L
  • Tabrizi, R
  • Cahn, J-Y
  • Michallet, M
  • Ambruso, D
  • Schots, R
  • Tissot, J-D
  • Sensebé, L
  • Kondo, T
  • McCullough, J
  • Rebulla, Paolo
  • Escolar, Gines
  • Mintz, P
  • Heddle, Nancy
  • Goodrich, RP
  • Bruhwyler, J
  • Le, C
  • Cook, RJ
  • Stouch, B

publication date

  • November 2010

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