Causality assessment of suspected virustransmission by human plasma products

Schosser, Rudolf; Keller‐Stanislawski, Brigitte; Nübling, C. Micha; Löwer, Johannes

doi:10.1046/j.1537-2995.2001.41081020.x

Cited by 13 publications

(16 citation statements)

References 72 publications

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“…The likelihood for a causal relationship between blood transfusion and virus infection was classified based on the guidelines of the German Advisory Group Blood (Opinion 34) or as described by Schosser and colleagues. 10,11 Causality assessment criteria include: "certain," "probable," "possible," "unlikely," and "nonassessable." There are several preconditions for the category "certain" to be fulfilled, including sufficient data for the assessment, a proper diagnosis of the viral infection, the clear identification of the administered product, and sufficient clinical plausibility for the transmission event (e.g., incubation time) associated with the treatment with the incriminated lot.…”

Section: Vigilance Reportsmentioning

confidence: 99%

Experience of mandatory nucleic acid test (NAT) screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions

et al. 2009

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Section: Vigilance Reportsmentioning

confidence: 99%

Experience of mandatory nucleic acid test (NAT) screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions

et al. 2009

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“…According to Opinion 34 regarding look-back procedures (German Advisory Group Blood) and according to published operational procedure [5], only 50 out of 3,322 notifications (1.5%) have been confirmed. …”

Section: Resultsmentioning

confidence: 99%

“…Regarding TTBI two measures were introduced, and for this reason, time periods before and after pre-donation sampling as well as before and after shelf life reduction of PC have been compared. An assessment of reported TRALI reactions on the basis of a standardised definition has been carried out since 2005 [5]. To evaluate the benefit of TRALI minimisation measures, we chose 2005-2008 as the time frame for the pre-implementation period and 2009-2013 for the post- implementation period.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of Risk Minimisation Measures for Blood Components - Based on Reporting Rates of Transfusion-Transmitted Reactions (1997-2013)

Funk

Heiden

Volkers

et al. 2015

Transfus Med Hemother

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Background: To assess the impact of safety measures, we compared reporting rates of transfusion-related reactions before and after the implementation of six measures in 1999, 2004, 2006, 2008 and 2009. Methods: Reporting rates of transfusion-transmitted bacterial infection (TTBI), viral infection (TTVI) and immune-mediated transfusion-related acute lung injury (TRALI) were calculated on the basis of confirmed annual reports and distributed blood components. Results: The introduction of HCV NAT testing caused a significant reduction of HCV reporting rate from 1:0.6 to 1:83.16 million administered blood components (p < 0.0001), donor screening for antibodies to hepatitis B core antigen caused a reduction of HBV reporting rate from 1:2.90 to 1:10.70 million units (p = 0.0168). A significant reduction from 1:0.094 to 1:2.42 million fresh frozen plasma (FFP) units could also be achieved by risk minimisation TRALI measures (p < 0.0001). Implementation of pre-donation sampling did not result in a significant decrease in TTBI, whereas limitation of shelf life for platelet concentrate (PC) minimised the TTBI reporting rate from 1:0.088 to 1:0.19 million PC units (p = 0.041). For HIV NAT pool testing, no significant reduction in HIV transmission was found due to very low reporting rates (1:10 million versus 1:27 million blood components, p = 0.422). Conclusion: On the basis of haemovigilance data, a significant benefit could be demonstrated for four of six implemented safety measures.

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“…In addition, the precipitation steps clear prions, the infectious agents associated with transmissible spongiform encephalopathies, away from the final product 29 . In this context, the role of appropriate analysis of causality in the putative transmission of blood borne pathogens is important 30 . This is exemplified by a report describing a patient who developed Creuzfeld Jakob disease following a liver transplant that included administration of a unit of albumin 31 .…”

Section: Adverse Events Associated With Albuminmentioning

confidence: 99%

Safety of Plasma Volume Expanders

Farrugia¹

2011

The Journal of Clinical Pharmacology

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Hypovolemia from a range of etiologies can lead to severe morbidity and mortality unless blood volume and tissue perfusion are restored. The treatment of hypovolemia has included the improvement and restoration of blood volume loss by the intravenous infusion of plasma expanding therapeutic agents. These have included crystalloid and/or colloid solutions, and a brisk controversy as to which modality is better has engaged therapeutics for the past 30 years. In addition, those favoring either modality have debated which crystalloid, and which colloid, is better. This area was given a dramatic turn a decade ago when a Cochrane meta-analysis concluded that albumin, a historically important plasma expander, resulted in increased mortality when administered to critically ill patients. Although subsequently modified by other studies, the Cochrane meta-analysis has served to generate an ongoing interest in the safety of plasma expanders. This review will assess the safety of these therapies from the viewpoint of the heterogeneous range of clinical indications for which they are used.

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Causality assessment of suspected virustransmission by human plasma products

Abstract: The algorithm is a tool for evaluating reports of suspected virus transmission in a standardized manner. It thus has the potential to improve early signal detection in pharmacovigilance of plasma products by confirmation or exclusion of suspected infectivity in most cases.

Cited by 13 publications

References 72 publications

Experience of mandatory nucleic acid test (NAT) screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions

Experience of mandatory nucleic acid test (NAT) screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions

Evaluation of Risk Minimisation Measures for Blood Components - Based on Reporting Rates of Transfusion-Transmitted Reactions (1997-2013)

Safety of Plasma Volume Expanders

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