Hemovigilance survey of pathogen‐reduced blood components in the Warsaw Region in the 2009 to 2013 period

Łętowska, Magdalena; Przybylska, Zofia; Piotrowski, Dariusz; Lachert, Elżbieta; Rosiek, Aleksandra; Rzymkiewicz, Lech; Cardoso, Marcia

doi:10.1111/trf.13330

Cited by 20 publications

(20 citation statements)

References 4 publications

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“…These reactions were considered possibly related to the transfusion of the blood product, implying a rate of 1.5% for adverse events related to transfusion. This rate is far below the observed rate of 8% reported elsewhere for pathogen-inactivated platelet products treated with an alternative technology, and consistent with prior reports on M-PT [11,14].…”

Section: Discussionsupporting

confidence: 90%

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

Vilariño

Castrillo

Campos

et al. 2016

Transfus Med Hemother

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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.

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Section: Discussionsupporting

confidence: 90%

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

Vilariño

Castrillo

Campos

et al. 2016

Transfus Med Hemother

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“…Although statistical power has not been achieved given the rarity of reported TA‐GVHD, these data are consistent with the in vitro and in vivo studies indicating that the amotosalen/UVA system prevents TA‐GVHD. Similar hemovigilance findings have been published for the riboflavin/UV system but are somewhat more limited, as they include a smaller number of transfused platelet units: 91,954 platelet concentrates over a period of 6 years in a number of European countries utilizing passive hemovigilance reporting …”

Section: Literature Review Of Ta‐gvhd Casessupporting

confidence: 67%

“…Similar hemovigilance findings have been published for the riboflavin/UV system but are somewhat more limited, as they include a smaller number of transfused platelet units: 91,954 platelet concentrates over a period of 6 years in a number of European countries utilizing passive hemovigilance reporting. 83,84…”

Section: Human Data On Ta-gvhd Preventionmentioning

confidence: 99%

Transfusion‐associated graft‐versus‐host disease reexamined: potential for improved prevention using a universally applied intervention

Kleinman

Stassinopoulos

2018

Transfusion

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BACKGROUND Transfusion‐associated graft‐versus‐host disease (TA‐GVHD) is a rare, often fatal complication of blood transfusion that can occur in immunocompromised or immunocompetent recipients and is the result of viable T cells present in the blood components transfused. STUDY DESIGN AND METHODS We examined the TA‐GVHD clinical case literature including numerous original clinical case reports and several comprehensive case series. We also evaluated recent in vitro experimental data on the inhibition of T cell proliferation, comparing the effect of a specific pathogen inactivation (PI) technology to that of the Food and Drug Administration–recommended gamma irradiation dose of 2500 cGy. RESULTS We identified 12 published TA‐GVHD cases with atypical/milder or delayed symptom presentations and/or an atypical clinical course; these included cases attributed to leukoreduced or suboptimally irradiated units. We summarize recent in vitro data using a sensitive limiting dilution assay that establish that, compared to irradiation at the recommended 2500 cGy dose, PI using amotosalen/ultraviolet A, or amustaline/glutathione achieves a greater degree of inhibition of T cell proliferation. CONCLUSION We propose that TA‐GVHD has a spectrum of disease severity indicating that additional mild cases may still occur but be undiagnosed and/or underreported, opening up the possibility, supported by in vitro experimental data, that irradiation at the currently established dose may not be fully protective. Furthermore, since many US institutions use component irradiation selectively only for immunocompromised patients, immunocompetent recipients are not fully protected. PI technologies appear to be at least equal to, if not better than, gamma irradiation in abrogating the ability of T cells to proliferate, and if applied to all blood components, protection against TA‐GVHD would be an additional benefit that would allow for the elimination of component irradiation.

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“…Additionally, our study showed that the frequency of febrile and allergic reactions in patients receiving PLT transfusions was lower in the PRT period despite the higher number of PLT concentrates transfused and the increase in the overall transfusion reaction notification rate to the BIHVS. Recent hemovigilance studies have also reported that the use of riboflavin and UV light–treated PLTs has the potential to reduce the frequency of transfusion reactions, specifically febrile and allergic reactions . It is known that PLTs suspended in an additive solution are associated with less allergic and febrile transfusion reactions than PLTs stored in 100% plasma .…”

Section: Discussionmentioning

confidence: 99%

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

2018

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Hemovigilance survey of pathogen‐reduced blood components in the Warsaw Region in the 2009 to 2013 period

Abstract: Treatment of blood components with the Mirasol PRT System has proven to be safe for patients and is not associated with increased rates and grades of adverse events in patients of hospitals in the Warsaw Region.

Cited by 20 publications

References 4 publications

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

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

Transfusion‐associated graft‐versus‐host disease reexamined: potential for improved prevention using a universally applied intervention

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

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