Title: To produce a cost effective immunoadsorption plasma filter for the production of blood group universal fresh frozen plasma and cryoprecipitate for transfusion.
Funder: Department of Health and Social Care

Abstract: Currently, plasma transfusion requires the donor and recipient to be blood group compatible. Plasma from donors of blood group AB is regarded as suitable for transfusion to any patient, because it does not contain anti-A or anti-B: if present these antibodies can bind to a patient's red blood cells causing haemolysis and even death. Only 4% of the UK population are group AB, and there is currently no alternative UP available in the UK, so group A plasma which has low levels of anti-B antibodies has been recommended as an alternative for when a patient s blood group is unknown. However, this practice is undesirable because: - there is a potential risk of haemolytic transfusion reactions developing in group B or AB individuals, especially when large volumes of plasma are transfused; - the wrong plasma group could be transfused to patients as a result of human error, particularly in emergency situations (these are considered never events in the NHS); - it delays the provision of plasma in bleeding situations, which could be detrimental to a patient s outcome; - it causes significant wastage of a precious resource in the NHS; - during mass casualty incidents it is difficult to meet the demand for AB and A plasma for NHS hospitals without compromising the supply of other blood components which are as important in these situations for treating injured patients. As the demand for plasma has increased over the last decade, and with the number of major incidents rising in the UK, there is a need for NHSBT to address these issues through developing a universal plasma. It is possible to remove anti-A and anti-B from plasma by filtration, and this project aims to develop a filter that could be applied to plasma of any blood group to render it universal (i.e. by removal of anti-A and anti-B). A team of transfusion laboratory and clinical medicine experts, together with commercial partners have shown in proof of principle studies that this is feasible and that the activity of processed-plasma is maintained. The objective of this project is to build upon this work by: a) scaling up production of the filter to support the manufacture of large-volumes of universal plasma suitable for routine use by global blood services, and b) complete pre-clinical evaluations ready for subsequent CE marking and development by industry. In addition to developing the filter, we will also consult with regulators, clinicians and patients to ensure that the performance of the filter meets their requirements and that it is safe and effective. We will transfer the technology and perform pre-clinical testing to a stage where it becomes commercially viable for a manufacturer to take forward to market. Key deliverables will be to demonstrate that: (i) a cost-effective manufacturing method to produce filters has been developed; (ii) the manufactured filters meet the design specification for plasma quality; (iii) the manufactured filters meet the required specification to remove target antibodies; (iv) the raw materials used are safe; (v) all required preclinical testing data is generated to support an application for CE marking/further clinical trials; (vi) the filter has been developed in accordance with ISO 13485:2016, (vii) a further survey is produced to assess the international market potential and barriers to adoption.

Lay abstract: Plasma is the constituent of blood which contains clotting factors: the proteins that make blood clot. It is transfused to treat severe bleeding, for example after trauma, surgery or childbirth. The patient s blood type (A, B, AB or O) must be compatible with the donor s blood type. Otherwise, antibodies in the donor s plasma (known as anti-A or anti-B) can attack the patient s red blood cells, causing anaemia or even death. In emergency situations, a patient s blood type might be unknown. Here, the safest option is to administer group AB plasma that is compatible with all blood types. However, only 4% of the population have AB blood, and thus there are very limited supplies. Therefore, unmatched plasma with low antibody levels is administered, to make it as safe as possible. But there is still a risk of transfusion reactions occurring if a large amount of plasma is transfused. Human error is a known risk. Between 2012 and 2015 there were nine reported UK cases of the wrong plasma type being selected. These cases are called never events : incidents which have the potential to cause serious patient harm or death but which are entirely preventable. NHS Blood and Transplant (NHSBT), the supplier of blood to hospitals, wish to develop a technology to remove anti-A and anti-B antibodies from donor plasma. This would enable production of a universal plasma, which would: - Reduce the risk of transfusion reactions. - Eliminate the risk of transfusing the wrong plasma type. - Speed up the delivery of plasma to patients. - Reduce wastage by allowing all plasma to be used. - Simplify plasma issuing for hospital laboratories, and reduce administration and logistical costs. - Make it easier for the NHS to supply sufficient quantities of plasma to any patient regardless of blood group

Research activity codes: 5.4 SURGERY
Health categories: BLOOD