Pathological transfusion reactions in recipients of COVID-19 convalescent plasma-Insights from SHOT

Convalescent plasma, donated by persons who have recently recovered from COVID-19, is the acellular component of blood that contains antibodies, including those that specifically recognise SARSCoV-2 virus. Safety and efficacy of COVID-19 Convalescent Plasma (CCP) was tested as part of two large randomised controlled trials (RCT) in UK (REMAP-CAP and RECOVERY). Serious Adverse Reactions (SAR) data relating to use of CCP reported to SHOT between April 2020 and Feb 2021 (inclusive) were reviewed. A total of 13 407 units of CCP were transfused under the two trials in the UK, with 11 477 (86%) of these given under RECOVERY. There were 14 confirmed SAR (one from REMAP-CAP and 13 relating to RECOVERY) equating to a risk of SAR of 1 in 958 units of CCP. The most common reactions seen in CCP recipients were pulmonary reactions (9/14, 64.3%). Transfusion-associated circulatory overload (TACO) was confirmed in 4 cases and transfusion associated dyspnoea (TAD) in the other 5. Moderate to severe febrile, allergic, hypotensive reactions were reported in 5 patients, all of whom recovered fully. Four patients with pulmonary reactions (3 with TACO and one with TAD) died with death possibly related to the transfusion complication. All reactions were reported in adult patients, with the average age being 65.6 years. TACO checklist was used in only 4/9 (44.4%) pulmonary reactions. One case of TAD was possibly preventable, all other cases were not. Significant co-morbidities were present in 9/14 (64.8%) cases, including COPD and cardiac disease (among many others). Imputablity assessment was challenging given the multisystem nature of severe COVID-19 illness-no reactions reported to SHOT have been noted by experts to be definitely related to CCP. The two large RCT from UK have helped establish the evidence that CCP does not improve survival or other clinical outcomes in patients hospitalised with COVID-19. A systematic review and meta-analysis published in February 2021 confirmed that treatment with CCP compared with placebo or standard of care was not significantly associated with a decrease in all-cause mortality or with any benefit for other clinical outcomes. Data from SHOT shows that the febrile, allergic hypotensive reactions and pulmonary complications were the most commonly reported reactions. Conclusion: The HFs day-to-day observation checklist was considered a useful tool for identifying behaviours that could lead to errors, waste in the system, staff injuries and lost time. The next step is to use the findings for change that will improve the process and lead to a better level of BMS engagement.