Efficacy of UVC-treated, pathogen-reduced platelets versus untreated platelets: a randomized controlled non-inferiority trial

Brixner, Veronika; Bug, Gesine; Pohler, Petra; Krämer, Doris; Metzner, Bernd; Voss, Andreas; Casper, Jochen; Ritter, Ulrich; Klein, Stefan; Alakel, Nael; Peceny, Rudolf; Derigs, Hans Günter; Stegelmann, Frank; Wolf, Martin; Schrezenmeier, Hubert; Thiele, Thomas; Seifried, Erhard; Kapels, Hans-Hermann; Döscher, Andrea; Petershofen, Eduard K.; Müller, Thomas; Seltsam, Axel

doi:10.3324/haematol.2020.260430

Cited by 10 publications

(10 citation statements)

References 45 publications

(10 reference statements)

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“…Overall, 4606 patients were enrolled in the 19 RCTs selected for the review. Of the 19 trials included in the systematic review, 10 compared Intercept ® PR-PLTs with St-PLTs [16,[18][19][20]22,23,25,30,32,34], 6 Mirasol ® PR-PLTs with St-PLTs [17,[26][27][28][29]31], 2 subgroups of patients receiving either Intercept ® or Mirasol ® PR-PLTs with St-PLTs [21,33], and 1 Theraflex ® PR-PLTs with St-PLTs [24] (Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…However, the results of platelet efficacy studies after inactivation are highly controversial. Some studies report that the PRTs can negatively impact platelet vitality and hemostatic function [16,17]; others, on the contrary, reaffirm platelet efficacy and safety after inactivation treatment compared with products not photochemically treated, and do not report an increase in adverse reactions in treated patients [17][18][19][20][21][22][23][24][25][26][27][28][29][30]; and other studies do not provide useful information [31][32][33][34].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs

Pati

Masiello²,

Pupella³

et al. 2022

Pathogens

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In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel–Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs

Pati

Masiello²,

Pupella³

et al. 2022

Pathogens

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“…Theraflex was very recently evaluated in a phase III clinical trial (CAPTURE), and the results were published online in February 2021 [ 65 ]. In a randomized, controlled, double blind, multicenter, non-inferiority trial, the group compared the efficacy and safety of UVC-treated platelets (UVC-PC) to that of untreated platelets in thrombocytopenic patients with hematologic-oncologic diseases.…”

Section: Resultsmentioning

confidence: 99%

Platelet Transfusion—Insights from Current Practice to Future Development

Capraru

Jalowiec

Medri

et al. 2021

JCM

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Since the late sixties, therapeutic or prophylactic platelet transfusion has been used to relieve hemorrhagic complications of patients with, e.g., thrombocytopenia, platelet dysfunction, and injuries, and is an essential part of the supportive care in high dose chemotherapy. Current and upcoming advances will significantly affect present standards. We focus on specific issues, including the comparison of buffy-coat (BPC) and apheresis platelet concentrates (APC); plasma additive solutions (PAS); further measures for improvement of platelet storage quality; pathogen inactivation; and cold storage of platelets. The objective of this article is to give insights from current practice to future development on platelet transfusion, focusing on these selected issues, which have a potentially major impact on forthcoming guidelines.

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“… 46,69,96 . Pathogen‐reduced PCs have been studied for their clinical effectiveness in 11 randomized controlled clinical trials, seven with INTERCEPT, 97–103 three with MIRASOL, 102,104,105 and one with THERAFLEX‐treated platelets 106 . The trials involved more than 2900 patients—~1900 patients in RCT with INTERCEPT, 860 patients with MIRASOL, and 87 with THERAFLEX.…”

Section: Clinical Studiesmentioning

confidence: 99%

Impact of different pathogen reduction technologies on the biochemistry, function, and clinical effectiveness of platelet concentrates: An updated view during a pandemic

Diaz‐Ricart¹,

Diaz-Ricart

McCullough

2021

Transfusion

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Standard platelet concentrates (PCs) stored at 22°C have a limited shelf life of 5 days. Because of the storage temperature, bacterial contamination of PCs can result in life‐threatening infections in transfused patients. The potential of blood components to cause infections through contaminating pathogens or transmitting blood‐borne diseases has always been a concern. The current safety practice to prevent pathogen transmission through blood transfusion starts with a stringent screening of donors and regulated testing of blood samples to ensure that known infections cannot reach transfusion products. Pathogen reduction technologies (PRTs), initially implemented to ensure the safety of plasma products, have been adapted to treat platelet products. In addition to reducing bacterial contamination, PRT applied to PCs can extend their shelf life up to 7 days, alleviating the impact of their shortage, while providing an additional safety layer against emerging blood‐borne infectious diseases. While a deleterious action of PRTs in quantitative and qualitative aspects of plasma is accepted, the impact of PRTs on the quality, function, and clinical efficacy of PCs has been under constant examination. The potential of PRTs to prevent the possibility of new emerging diseases to reach cellular blood components has been considered more hypothetical than real. In 2019, a coronavirus‐related disease (COVID‐19) became a pandemic. This episode should help when reconsidering the possibility of future blood transmissible threats. The following text intends to evaluate the impact of different PRTs on the quality, function, and clinical effectiveness of platelets within the perspective of a developing pandemic.

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Efficacy of UVC-treated, pathogen-reduced platelets versus untreated platelets: a randomized controlled non-inferiority trial

Cited by 10 publications

References 45 publications

Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs

Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs

Platelet Transfusion—Insights from Current Practice to Future Development

Impact of different pathogen reduction technologies on the biochemistry, function, and clinical effectiveness of platelet concentrates: An updated view during a pandemic

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