Pathogen-reduced platelets for the prevention of bleeding

Abstract

Background Platelet transfusions are used to prevent and treat bleeding in people who are thrombocytopenic. Despite improvements in donor screening and laboratory testing, a small risk of viral, bacterial, or protozoal contamination of platelets remains. There is also an ongoing risk from newly emerging blood transfusion-transmitted infections for which laboratory tests may not be available at the time of initial outbreak. One solution to reduce the risk of blood transfusion-transmitted infections from platelet transfusion is photochemical pathogen reduction, in which pathogens are either inactivated or significantly depleted in number, thereby reducing the chance of transmission. This process might offer additional benefits, including platelet shelf-life extension, and negate the requirement for gamma-irradiation of platelets. Although current pathogen-reduction technologies have been proven to reduce pathogen load in platelet concentrates, a number of published clinical studies have raised concerns about the effectiveness of pathogen-reduced platelets for post-transfusion platelet count recovery and the prevention of bleeding when compared with standard platelets. This is an update of a Cochrane review first published in 2013. Objectives To assess the effectiveness of pathogen-reduced platelets for the prevention of bleeding in people of any age requiring platelet transfusions. Search methods We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 9), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 24 October 2016. Selection criteria We included RCTs comparing the transfusion of pathogen-reduced platelets with standard platelets, or comparing different types of pathogen-reduced platelets. Data collection and analysis We used the standard methodological procedures expected by Cochrane. Main results We identified five new trials in this update of the review. A total of 15 trials were eligible for inclusion in this review, 12 completed trials (2075 participants) and three ongoing trials. Ten of the 12 completed trials were included in the original review. We did not identify any RCTs comparing the transfusion of one type of pathogen-reduced platelets with another. Nine trials compared Intercept® pathogen-reduced platelets to standard platelets, two trials compared Mirasol® pathogen-reduced platelets to standard platelets; and one trial compared both pathogen-reduced platelets types to standard platelets. Three RCTs were randomised cross-over trials, and nine were parallel-group trials. Of the 2075 participants enrolled in the trials, 1981 participants received at least one platelet transfusion (1662 participants in Intercept® platelet trials and 319 in Mirasol® platelet trials). One trial included children requiring cardiac surgery (16 participants) or adults requiring a liver transplant (28 participants). All of the other...

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

“…In fact, the authors state that although PRT‐treated PLTs lead to an increased requirement for PLT transfusion, there is no evidence that they affect the risk of death, bleeding, or a serious side effect. The authors also point out that there is still insufficient evidence for patients with other diagnoses …”

“…The authors also point out that there is still insufficient evidence for patients with other diagnoses. 40 Currently in progress, the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial, a randomized, single-blinded, multicenter controlled trial, is aiming to evaluate the clinical noninferiority of riboflavin and UV light-treated PLTs compared with conventional PLTs, using the percentage of patients with WHO Grade 2 or more bleeding complications as the primary outcome. 41 It will be very interesting to see the results of this promising study, as it is likely to shed light on the true safety and efficacy profile of riboflavin and UV lighttreated PLTs.…”

Failure of bacterial screening to detect Staphylococcus aureus: the English experience of donor follow‐up

“…A number of measures have served to reduce the risk of bacterial contamination of blood components; these include strict donor selection criteria, effective skin cleansing, diversion and discard of an initial fraction of the donation, bacterial screening and pathogen reduction technologies . Platelet components are susceptible to bacterial contamination due to their storage at 22 ± 2°C.…”

Platelet safety strategies in Japan: impact of short shelf life on the incidence of septic reactions

“…Contaminated units can be detected by screening PC samples by culture methods and by visually inspecting components, or by rapid tests immediately before transfusion . The bacterial load can be reduced using pathogen reduction techniques that have been developed and introduced in some countries as an ultimate solution to this issue . However, each of these methodologies has advantages and disadvantages with respect to clinical outcomes; workload on staff not only at blood facilities, but also medical institutions that deal with the mitigating procedures; time constraints; complicated logistics derived from the short shelf life of PC; and the cost of introducing and maintaining mitigation measures.…”