A feasibility study examining the potential of introducing a whole blood component for the management of traumatic major haemorrhage

McCullagh, Josephine Anne (2023) A feasibility study examining the potential of introducing a whole blood component for the management of traumatic major haemorrhage. Doctoral thesis (DClinSci), Manchester Metropolitan University.

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Abstract

Background The timely and organised approach of transfusing trauma patients in the pre-hospital setting with a 1:1:1 ratio of red blood cells, plasma and platelets has resulted in an increased interest in re-introducing whole blood (WB) components for the management of these patients. WB components are not used routinely in NHS hospitals, but should the blood service decide to implement this component in the prehospital setting, further evidence is required on: a) its safety, because these patients will be transfused group O WB which contains anti-A and anti- B in the plasma that can result in haemolytic transfusion reactions and b) the logistics of supplying group O negative WB to prehospital services, considering that demand for this component currently outstrips supply. The overall research question in this thesis was to establish whether it is safe and feasible to introduce a WB component in the NHS for the treatment of traumatic major haemorrhage in the pre-hospital setting. Specific objectives were to: a) Determine the lowest observable anti-A and anti-B titre (measured by IgG or IgM), and the lowest observable ABO incompatible plasma volume that have been reported in the literature to have resulted in haemolysis in recipients receiving ABO incompatible plasma containing components (scoping review). b) Determine a) the clinical safety of transfusing LD-RCP to trauma patients; b) whether the component was delivered to hospital on time in full (OTIF) and c) the overall component wastage for the hospital. Through the evaluation of a similar component to WB (i.e., leucocyte-depleted Red Cell and Plasma [LD-RCP]) with regards to shelf life, logistical and serological issues (2-year observational study). c) Explore the stock management of a WB component using data collected from the 2- year observational study (stock management). Results Scoping review In this first ever systematic scoping review, assessing the risk of haemolysis following the transfusion of ABO incompatible plasma-containing components, 62 eligible cases were identified. There were no completed or ongoing randomised trials. There was heterogeneity between cases in the methods for reporting haemolysis and ABO titration methods, while the volume was poorly reported. Putting all these aside, results showed that platelet components were the most reported components to result in haemolysis in both paediatrics and adults. The lowest anti-A titre reported to cause haemolysis was 32 (paediatrics and adult), while for anti-B it was 512 (IgG and IgM) for adults, 16,384 for paediatrics (IgG and IgM) and 128 (IgM) in cases where the age was not specified. The lowest component volume transfused that was reported to have caused a haemolytic transfusion reaction was 100ml in adults and 15mls in paediatric. Observational study Of the 204 patients who were transfused group O RhD negative LD-RCP (a maximum of 4 units), 96 patients had a blood group recorded and were non-group O. Based on the results of haemoglobin, bilirubin and Direct Antiglobulin Tests (DAT), there was no evidence of increased haemolysis compared to patients who were blood group O and who also received group O RhD negative LD-RCP. During the study, 1208 units (96.5%) of LD-RCP units were delivered to hospital on time and as per specifications, which met the pre-agreed study target of 97% (95% Confidence Interval: 96% - 98%). Despite this, not all units were delivered at age 2 days old with only 64.7% of the total units being delivered on the agreed age. Following the quality improvement work undertaken by the study team, there was a marked improvement in the age of units delivered with 91.7% being delivered at the pre-agreed age towards the end of the study, demonstrating that delivering at age 2 days old is feasible. Component wastage (39%) was a major concern during this study and the pre-agreed wastage level target of <8% was not met. Nevertheless, incremental reductions were demonstrated across the study period, reducing the weekly wastage from a mean of 8.36 units per week (70%) to 3.19 (27%) by the end of the study period. Stock management Based on the data collected from the observational study, evaluation of pre-hospital component demand using ARIMA time series forecasting showed that the demand for prehospital transfusion was random and could not be forecasted to a usable degree. Using a combination of a First In First Out (FIFO) inventory model and a Poisson distribution to model component demand, two stock management models were developed (14-day shelf life and 21-day shelf life). Using heuristically generated component supply algorithms the stock management model demonstrated that component wastage could be reduced to 16% and 4% for a 14-day and 21-day shelf-life component, respectively. Conclusion Incorporating evidence from a scoping review, data collected as part of a 2-year observational study using a similar component to WB (LD-RCP) and mathematical modelling of the supply and demand, this thesis provides evidence that the transfusion of group O WB components in the prehospital setting is a safe and feasible intervention in the NHS for the treatment of traumatic haemorrhage. However, if the component is only used in this setting, the component wastage level for hospitals is likely to be high, and therefore measures such as extending the shelf-life of the WB component and incorporating a dynamic inventory model for component supply must be considered to minimise the wastage of this precious resource.