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

Authors

Scott A. Koepsell, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Moritz Stolla, Division of Hematology, Department of Medicine, University of Washington, Seattle, Washington, USA.
Rebecca L. Sedjo, Clinical Research and Development, Terumo BCT, Inc., Lakewood, Colorado, USA.
Jeffrey Carson, Department of Medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
Michael Knudson, Department of Pathology, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.
Richard Cook, Lifetime Scientific Inc., Waterloo, Ontario, Canada.
Ross Fasano, Center for Transfusion and Cellular Therapies, Department of Pathologyand Laboratory Medicine, Emory University School of Medicine, Atlanta, GA.
Samantha G. Ngamsuntikul, South Texas Blood and Tissue, San Antonio, Texas, USA.
Claudia Cohn, Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.
Jed Gorlin, Memorial Blood Centers, Minneapolis, Minnesota, USA.
Meghan Delaney, Department of Pathology, Children's National Hospital and The George Washington University School of Medicine, Washington, DC, USA.
Sherrill Slichter, Department of Medicine, Division of Hematology, University of Washington, Seattle, Washington, USA.
Paul Ness, Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA.
Jeffrey McCullough, Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.

Document Type

Journal Article

Publication Date

3-1-2024

Journal

Transfusion

Volume

64

Issue

3

DOI

10.1111/trf.17720

Keywords

hematology; platelet transfusion; platelets; transfusion-transmitted disease

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.

APA Citation

Koepsell, Scott A.; Stolla, Moritz; Sedjo, Rebecca L.; Carson, Jeffrey; Knudson, Michael; Cook, Richard; Fasano, Ross; Ngamsuntikul, Samantha G.; Cohn, Claudia; Gorlin, Jed; Delaney, Meghan; Slichter, Sherrill; Ness, Paul; and McCullough, Jeffrey, "Results of clinical effectiveness of conventional versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MiPLATE) trial" (2024). GW Authored Works. Paper 4287.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/4287

Department

Pathology