Assessing the risk of transfusion-transmitted variant Creutzfeldt-Jakob disease: a European perspective.

Several countries have recently reassessed the international risk of variant Creutzfeldt-Jakob disease (vCJD) transmission through transfusion of blood and blood components (red blood cells, platelets and plasma) and relaxed donor deferrals based on geographic and transfusion exposure in countries formerly considered to be high risk, such as the UK. In this regard, the European Blood Alliance organised a consensus meeting of experts and involved professionals to discuss current knowledge, epidemiological data, prevention and various methods for assessing the risk of transfusion-transmitted vCJD, as well as to develop an appropriate position on possible approaches to address these challenges in Europe. Participants reached a consensus that the current risk of transfusion-transmitted vCJD associated with blood donors who either travelled to or received transfusions in the UK during the vCJD outbreak is minimal. In addressing such risks, it would be pragmatic that assessments and guidelines are developed by European expert bodies, rather than individual assessments by Member States. Regardless of the approach used, European or national, a qualitative risk assessment based on a review and analysis of available data, considering all the uncertainties and experiences of other countries, would provide crucial information to reassess blood donation strategies regarding the transfusion-associated vCJD risk.

Safety profile of plasma for fractionation donated in the United Kingdom, with respect to variant Creutzfeldt-Jakob disease.

Plasma-derived medicinal products (PDMPs) are life-saving and life-improving therapies, but the raw material is in short supply: Europe depends on importation from countries including the United States. Plasma from donors resident in the United Kingdom has not been fractionated since 1999 when a precautionary measure was introduced in response to the outbreak of variant Creutzfeldt-Jakob disease (vCJD). Cases of vCJD have been far fewer than originally predicted in the 1990s. Since the introduction of leucodepletion in 1999, and accounting for the incubation period, more than 40 million UK-derived blood components have been issued with no reports of TT vCJD. In February 2021, the UK Government authorized manufacture of immunoglobulin from UK plasma. Following separate reviews concluding no significant difference in the risk posed, the United States, Australia, Ireland and Hong Kong also lifted their deferrals of blood donors with a history of living in the United Kingdom. Other countries are actively reviewing their position. Demand is rising for PDMPs, and Europe faces a threat of supply shortages. Industry and patient groups are clear that using UK plasma would bring significant immediate benefits to patients and to the resilience of the European supply chain. From this scientific review, we conclude that UK plasma is safe for fractionation and urge blood regulators and operators to take account of this safety profile when considering fractionation of UK plasma, and to revise their guidelines on the deferral of donors who have lived in, or received a transfusion in, the United Kingdom.

Modelling the outcomes of different red blood cell transfusion strategies for the treatment of traumatic haemorrhage in the prehospital setting in the United Kingdom.

BACKGROUND AND OBJECTIVES: The limited supply and increasing demand of group O RhD-negative red blood cells (RBCs) have resulted in other transfusion strategies being explored by blood services that carry potential risks but may still provide an overall benefit to patients. Our aim was to analyse the potential economic benefits of prehospital transfusion (PHT) against no PHT. MATERIALS AND METHODS: The impact of three PHT strategies (RhD-negative RBC, RhD-positive RBC and no transfusion) on quality-adjusted-life-years (QALYs) of all United Kingdom trauma patients in a given year and the subset of patients considered most at risk (RhD-negative females <50 years old), was modelled. RESULTS: For the entire cohort and the subset of patients, transfusing RhD-negative RBCs generated the most QALYs (141,899 and 2977, respectively), followed by the RhD-positive RBCs (141,879.8 and 2958.8 respectively), and no prehospital RBCs (119,285 and 2503 respectively). The QALY difference between RhD-negative and RhD-positive policies was smaller (19.2, both cohorts) than RhD-positive and no RBCs policies in QALYs term (22,600 all cohort, 470 for a subset), indicating that harms from transfusing RhD-positive RBCs are lower than harms associated with no RBC transfusion. A survival increase from PHT of 0.02% (entire cohort) and 0.7% (subset cohort) would still make the RhD-positive strategy better in QALYs terms than no PHT. CONCLUSION: While the use of RhD-positive RBCs carries risks, the benefits measured in QALYs are higher than if no PHT are administered, even for women of childbearing potential. Group O RhD-positive RBCs could be considered when there is a national shortage of RhD-negative RBCs.