Clinical effectiveness of platelets in additive solution treated with two commercial pathogen‐reduction technologies

Abstract

Although conclusions on noninferiority could not be drawn due to low statistical power, the study provides additional information on the safety and efficacy of pathogen-reduced platelets treated with two commercial pathogen-reduction technologies.

Our experience in riboflavin and ultraviolet light pathogen reduction technology for platelets: from platelet production to patient care

“…There is a lack of correlation between in vitro results and clinical efficacy . Interestingly, as shown by the clinical trials available to date, even when riboflavin and UV light–treated PLTs are associated with a lower CCI or posttransfusion PLT count, this is not linked with an increased risk of bleeding …”

Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

“…13,14 However, studies have shown an association between PR platelets and a reduction in 1-and 24-hour corrected count increments, increase in platelet refractoriness, decrease in time to next transfusion, and increase in platelet use. [15][16][17] The most recent study demonstrated a 50% increase in platelets transfused and a 25% increase in red blood cells transfused in patients receiving INTERCEPT vs control platelets. 16 The increase in platelet use will also impact the national platelet inventory.…”

“…[15][16][17] The most recent study demonstrated a 50% increase in platelets transfused and a 25% increase in red blood cells transfused in patients receiving INTERCEPT vs control platelets. 16 The increase in platelet use will also impact the national platelet inventory.…”

Ultraviolet light‐based pathogen inactivation and alloimmunization after platelet transfusion: results from a randomized trial

“…The ideal method for testing whether PRT affects the rate of alloimmunization in recipients of treated platelets would be a randomized controlled trial of PRT versus conventional platelet transfusion. The Italian Platelet Technology Assessment Study (IPTAS) performed two parallel, randomized clinical trials of PR‐treated versus conventional platelets in patients who had hematologic malignancies and were beginning chemotherapy . Patients from three hospitals were randomized to receive Mirasol versus conventional platelets, and patients from three different hospitals were randomized to receive Intercept versus conventional platelets.…”

“…The primary trial was designed to measure whether the PR‐treated products were noninferior to conventional platelets, with the primary endpoint of Grade 2 or greater bleeding. In the IPTAS trial, there was no statistically significant increased risk of Grade 2 or greater bleeding in the PRT platelet arms compared with the conventional platelet arms, although the trial did not meet its enrollment target, so conclusions regarding noninferiority could not be drawn . The current analysis was designed as an ancillary study to accompany the IPTAS trial to determine whether the receipt of PRT platelets reduced the risk of HLA alloimmunization.…”