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

Transfusion. 2010 Nov;50(11):2362-75. doi: 10.1111/j.1537-2995.2010.02694.x.

Abstract

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Bacterial Infections / prevention & control*
  • Blood Platelets / drug effects
  • Blood Platelets / radiation effects
  • Blood Preservation / adverse effects
  • Blood Preservation / methods*
  • Female
  • Follow-Up Studies
  • Hematologic Neoplasms / complications
  • Hemorrhage / etiology
  • Humans
  • Male
  • Middle Aged
  • Platelet Count
  • Platelet Transfusion / adverse effects
  • Platelet Transfusion / methods*
  • Riboflavin / adverse effects
  • Riboflavin / pharmacology*
  • Thrombocytopenia / etiology
  • Thrombocytopenia / therapy*
  • Treatment Outcome
  • Ultraviolet Rays*
  • Young Adult

Substances

  • Riboflavin