Mirasol®-Treated Platelets Show No Clinical Difference in Reducing Bleeding From Conventional Platelets in Plasma
LAKEWOOD, Colo., May 17, 2018 /PRNewswire/ — The results of the PREPAReS clinical trial were published today in Blood, the official journal of the American Society of Hematology. The trial evaluated the effectiveness of buffy-coat-derived platelets in plasma treated by the Mirasol® Pathogen Reduction Technology (PRT) System. The trial results add to the growing clinical evidence that platelets treated by Terumo BCT’s Mirasol are safe and effective.
The trial was coordinated by Sanquin Blood Supply Foundation, a not-for-profit organization responsible for clinical transfusion research and for the blood supply in the Netherlands. The trial results were authored in Blood by a team led by Pieter van der Meer, Ph.D., senior scientist at Sanquin. Terumo BCT collaborated in the trial and is a global leader in blood component, therapeutic apheresis and cellular technologies.
To date, PREPAReS is the most comprehensive clinical trial comparing Mirasol-treated platelets to conventional platelets in plasma prepared using the buffy coat method. The clinical trial concluded that when it comes to stopping bleeding there was no clinical difference (noninferiority) between the treated and conventional platelets.
The primary endpoint of the PREPAReS trial was met, as demonstrated by the intent to treat (ITT) analysis, which represents how a transfused blood product is used in a real-world setting. The trial analyzed the percentage of patients with a bleeding event equal to or greater than grade 2 on the World Health Organization (WHO) bleeding scale.
“The PREPAReS results are very meaningful for all healthcare providers concerned about the ongoing safety of blood as we continue to see new pathogens emerge,” says Jean-Louis Kerkhoffs, a senior researcher at the Department of Clinical Transfusion Research at Sanquin and a hematologist in The HagaZiekenhuis in The Hague.
PREPAReS, or Pathogen Reduction Evaluation & Predictive Analytical Rating Score, was a multicenter, randomized, controlled phase 3 trial conducted at ten hospitals with 567 transfusion treatment periods of more than 3,000 platelet units to 469 patients in Canada, Norway and the Netherlands. It evaluated patients with thrombocytopenia, a low-platelet-count condition that is frequently caused either by illnesses such as leukemia or as a side effect of medications such as chemotherapy drugs.
Thrombocytopenia patients receive platelet transfusions when the number of platelets in circulation is too low to prevent bleeding. Some thrombocytopenic patients receive many transfusions, so ensuring the safety of the blood products is critical.
Advancing Blood Safety
“Terumo BCT is dedicated to advancing blood safety throughout the world. Mirasol is a proactive approach to protecting patients, including those who frequently need transfusions,” says Palani Palaniappan, Executive Vice President, Innovation and Development, Terumo BCT. “We continue working toward global adoption of Mirasol.”
Using riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites and bacteria in blood products before they are transfused to patients. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.
Mirasol is CE marked for platelets, plasma and whole blood and is in use in 140 blood centers in more than 20 countries in select markets throughout Europe, the Middle East, Africa, Asia and Latin America. The system is for investigational use only in the U.S. and Canada.
About Terumo BCT
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
About Sanquin Blood Supply Foundation
Sanquin is responsible for a safe and efficient blood supply in the Netherlands on a not-for-profit basis. This is possible because hundreds of thousands of donors voluntarily give blood. The core activity is safe and efficient production and distribution of blood and plasma products for the treatment of patients. Sanquin also develops and produces pharmaceutical products, conducts high-quality scientific research, and develops and performs a multitude of diagnostic services.
Sanquin Blood Supply Foundation
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SOURCE Terumo BCT