Results of clinical effectiveness of conventional versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MiPLATE) trial

Scott A. Koepsell, Moritz Stolla, Rebecca L. Sedjo, Jeffrey Carson, Michael Knudson, Richard Cook, Ross Fasano, Samantha G. Ngamsuntikul, Claudia Cohn, Jed Gorlin, Meghan Delaney, Sherrill Slichter, Paul Ness, Jeffrey McCullough

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Mirasol® Pathogen Reduction Technology System was developed to reduce transfusion-transmitted diseases in platelet (PLT) products. Study Design and Methods: MiPLATE trial was a prospective, multicenter, controlled, randomized, non-inferiority (NI) study of the clinical effectiveness of conventional versus Mirasol-treated Apheresis PLTs in participants with hypoproliferative thrombocytopenia. The novel primary endpoint was days of ≥Grade 2 bleeding with an NI margin of 1.6. Results: After 330 participants were randomized, a planned interim analysis of 297 participants (145 MIRASOL, 152 CONTROL) receiving ≥1 study transfusion found a 2.79-relative rate (RR) in the MIRASOL compared to the CONTROL in number of days with ≥Grade 2 bleeding (95% confidence interval [CI] 1.67–4.67). The proportion of subjects with ≥Grade 2 bleeding was 40.0% (n = 58) in MIRASOL and 30.3% (n = 46) in CONTROL (RR = 1.32, 95% CI 0.97–1.81, p =.08). Corrected count increments were lower (p <.01) and the number of PLT transfusion episodes per participant was higher (RR = 1.22, 95% CI 1.05–1.41) in MIRASOL. There was no difference in the days of PLT support (hazard ratio = 0.86, 95% CI 0.68–1.08) or total number of red blood cell transfusions (RR = 1.12, 95% CI 0.91–1.37) between MIRASOL versus CONTROL. Transfusion emergent adverse events were reported in 119 MIRASOL participants (84.4%) compared to 133 (82.6%) participants in CONTROL (p = NS). Discussion: This study did not support that MIRASOL was non-inferior compared to conventional platelets using the novel endpoint number of days with ≥Grade 2 bleeding in MIRASOL when compared to CONTROL.

Original languageEnglish (US)
Pages (from-to)457-465
Number of pages9
JournalTransfusion
Volume64
Issue number3
DOIs
StatePublished - Mar 2024

Keywords

  • hematology
  • platelet transfusion
  • platelets
  • transfusion-transmitted disease

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

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