Assessment of the Clinical Performance of Platelet Concentrates Treated by Pathogen Reduction Technology in Santiago de Compostela

Abstract

Introduction: This study assessed the feasibility, performance, and safety of Mirasol®-treated platelet concentrates (M-PC) stored for up to 7 days. Methods: This prospective observational study was approved by the ethical committee of the University Clinic of Santiago de Compostela. Informed consent was asked from patients receiving M-PC. M-PCs were treated with the Mirasol system according to the manufacturer's instructions. Thrombocytopenic patients were transfused according to the Spanish transfusion guidelines. Post-transfusion platelet counts were measured at 1 h and/or 24 h after transfusion. Post-transfusion surveillance of patients was maintained during the study. Results: Data from 54 evaluable patients and 135 transfusions were analyzed. The mean age of patients was 58 years. The mean age of M-PC at transfusion was 3.6 days. The mean platelet dose was 3.7 × 10¹¹. The transfusion responses measured as mean corrected count increment 1 h after transfusion (CCI_1h) and CCI_24h were 9,659 and 4,751, respectively. 65% of transfusions resulted in CCI_1h values ≥ 7,500. 51% of transfusions resulted in CCI_24h values ≥ 4,500. Conclusion: The use of M-PC in the supportive treatment proved to be safe and effective for this cohort of thrombocytopenic patients.

Refrigeration, cryopreservation and pathogen inactivation: an updated perspective on platelet storage conditions

“…While extensive haemovigilance studies have demonstrated that Mirasol and INTERCEPT pathogen inactivated platelets have a similar safety profile to untreated platelets , there is conflicting evidence regarding the in vivo survival and efficacy of these platelets . Further, a recent systematic review has suggested that transfusion of pathogen inactivated platelets increases transfusion requirements and the risk of developing platelet refractoriness , although there are also data to the contrary .…”

In Vitro Comparative Study of Platelets Treated with Two Pathogen-Inactivation Methods to Extend Shelf Life to 7 Days

“…The hemostatic efficacy of pathogen-inactivated vs untreated platelets was assessed in several clinical trials for AM-PI with up to 5-day [ 10 , 11 ] or 7-day storage [ 12 ], and for RF-PI with 5-day shelf life [ 13 , 14 , 15 ]. A single-arm study investigated the clinical performance of RF-PI with CCI as a primary outcome with up to 7-day storage [ 16 ]. Recent studies investigated platelet use in real-life conditions with up to 7-day storage for AM-PI [ 17 , 18 ], and did not show a significantly increased consumption.…”