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BACKGROUND AND OBJECTIVE: Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle. MATERIALS AND METHODS: From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence. RESULTS: The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process. CONCLUSIONS: While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.
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Donantes de Sangre , Seguridad de la Sangre/métodos , Selección de Donante/normas , Humanos , Medición de RiesgoRESUMEN
INTRODUCTION/BACKGROUND: At the beginning of the COVID-19 pandemic, eye banks around the world had to assess the impact of SARS-CoV-2 infection in potential ocular tissue donors and decide how to characterise donors to meet ongoing demand for tissue for transplantation.NHSBT eye banks normally issue cornea grafts for over 4000 transplants per annum (pre-pandemic). SARS-CoV2 RNA screening is not a requirement for eye donor characterisation. Donor authorisation is based on review of donor medical and contact history and any available COVID test results (e.g. from hospital testing or as part of organ donor characterisation). After retrieval, globes are disinfected with PVP-iodine, and corneas stored in organ culture.This presentation explores the impact of COVID-19 on corneal donation and transplantation in England. METHODS: UK Transplant Registry data were analysed on all corneal donors and transplants in England from 1 January 2020 to 2 July 2021. All laboratory confirmed SARS CoV-2 infections were collected by Public Health England from 16 March 2020. Information was available until mid-November 2021.To assess the possibility of transmission through a transplanted graft, cases with a diagnosis of infection within 14 days post transplant were identified for further review. RESULTS: 4130 corneal grafts were performed in England. We are aware of 222 recipients who tested positive for SARS-CoV2. 2 of these have been reported to have died within 28 days of testing positive. The diagnosis of SARS-CoV2 infection in these 2 recipients had been made beyond 30 days post transplant.In 3 of the 222 infected recipients, the interval between transplant and infection was within 14 days (all 3 recipients alive). 2 of the 3 donors were fully characterised organ donors (universally screened for SARS-CoV-2 RNA in upper and lower respiratory tract samples), and one was an eye only donor who had tested negative in hospital 2 days prior to death. CONCLUSIONS: The linkage of large registries allows collection of useful data in a large cohort of patients transplanted during the COVID-19 pandemic. The incidence of COVID-19 and characteristics of corneal transplant recipients who tested positive for SARS-CoV2 were found to be similar to those for the general population of England.These data have not identified any epidemiological evidence for transmission of COVID-19 through corneal transplantation, and offer reassurance about the safety and quality systems that are in place to allow ongoing corneal transplantation during the pandemic.
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COVID-19 , Trasplante de Córnea , Humanos , COVID-19/diagnóstico , ARN Viral , SARS-CoV-2/genética , Pandemias , Inglaterra/epidemiologíaRESUMEN
NHS Blood and Transplant (NHSBT) Tissue and Eye Services (TES) save and improve the lives of thousands of patients every year.The Clinical Support Nurse Team (CSNT) within TES is an example of registered nurses working at an advanced level, making professionally autonomous decisions for which they are accountable.The concept of nurses working at this level began with a pilot study in 2012 under a robust governance system and change process within NHSBT. The development and progress of the team has also been reviewed by NHSBT Clinical Audit.The CSNT currently comprises two band 7 nurses and a band 8a manager who work together to safely assess and authorise donated tissue for transplant. There are plans to expand the team in 2022 and to ensure that the work is underpinned by a suitable academic framework that reflects the level of clinical responsibility. The CSNT work in conjunction with TES medical consultants who provide education, guidance and governance.The team is required to use complex reasoning, critical thinking, reflection and analysis to inform their assessment and clinical judgement.CSNT practice is guided by the Donor Selection Guidelines set by the Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (2013). These guidelines stipulate contraindications to tissue donation on which the CSNT bases clinical decisions to ensure the safety of the recipients of any donated tissue by ruling out the chances of contracting any transmissible illness or transplanting tissue of compromised quality.Although a large component of the TES CSNT workload is to authorise donor files from deceased donors there are also living donation programmes. CSNT also review the Autologous/Allogeneic Serum Eye Drop Programme (ASE/AlloSE). This involves reviewing clinical requests made by ophthalmologists for serum eye drop options.This is a brief summary of how CSNT nurses apply their expert knowledge and skills to a broad range of Clinically challenging and complex situations.
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Obtención de Tejidos y Órganos , Humanos , Proyectos Piloto , Donantes de Tejidos , Reino UnidoRESUMEN
BACKGROUND: Since the late 1990s there has been increasing demand for donated granulocyte transfusions to treat or prevent severe infections in patients who lack their own functional granulocytes. Other than in neonates, no systematic reviews have been performed for over 10 years relating to the efficacy of prophylactic granulocyte transfusions. OBJECTIVES: To determine the effectiveness and safety of granulocyte transfusions compared with a control population not receiving this intervention for preventing mortality due to infection or due to any other cause in patients with neutropenia or disorders of neutrophil function. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 3, 2008, MEDLINE, EMBASE and other specialised databases up to October 2008. We also searched reference lists of articles and contacted experts in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing patients receiving granulocyte transfusions to prevent the development of infection with a control group receiving no granulocyte transfusions. Neonates have been the subject of a recent review and were excluded. There was no restriction by outcomes examined, but this review focuses on mortality, mortality due to infection and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed potentially relevant studies for inclusion. Data were extracted by two review authors and the methodological quality was examined. Data were analysed using random and fixed effects models. MAIN RESULTS: Ten trials met the inclusion criteria. Allocation in all trials was random, with the control arm receiving no prophylactic therapy, except one trial in which the control group received specific prophylactic antibiotics. One study reported biological randomisation based upon the availability of suitably matched, related donors rather than strict randomisation. All trials were conducted over twenty years ago with one exception, a study from 2006 in which donors were pre-medicated with granulocyte colony stimulating factor (G-CSF) resulting in significantly higher mean doses of granulocytes collected for transfusion. Different policies otherwise applied for the schedule for transfusion, method of granulocyte procurement and criteria for defining infection. Combining the results showed a relative risk (RR) for mortality of 0.94 (95% confidence intervals (CI) 0.71 to 1.25). Exclusion of the two trials which reported transfusion of an average number of granulocytes below 1 x 10(10) indicated a summary RR for mortality and mortality due to infection of 0.89 (CI 0.64 to 1.24) and 0.36 (0.14 to 0.96) respectively. IMPLICATIONS FOR CLINICAL PRACTICE: The controlled trials that have been identified raise the possibility that prophylactic granulocyte transfusions at a dose of at least 1 x 10(10) may reduce the risk of mortality from infection. Overall mortality was not affected. However, the majority of studies were performed decades ago, and standards of supportive care have advanced considerably. These earlier trials were also based on transfusing lower yields of collected granulocytes than currently recommended. It is difficult to recommend prophylactic granulocyte transfusions outside the setting of ongoing controlled trials, given the resource and cost implications. IMPLICATIONS FOR RESEARCH: Larger trials are needed to establish the validity of the potential benefits raised by this review, in view of the methodological limitations, the small sample sizes and the heterogeneous definitions of infection that were encountered in the included studies.
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Infecciones Bacterianas/prevención & control , Granulocitos/trasplante , Transfusión de Leucocitos/métodos , Micosis/prevención & control , Neutropenia/terapia , Antibacterianos/uso terapéutico , Antifúngicos/uso terapéutico , Glucocorticoides/uso terapéutico , Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Humanos , Trastornos Leucocíticos/complicaciones , Trastornos Leucocíticos/terapia , Neutropenia/complicaciones , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
This study assessed the effect on coagulation tests of fresh frozen plasma (FFP), given according to guidelines compared with higher doses in critically ill patients. Group 1 (10 patients) received 12.2 ml/kg and group 2 (12 patients) 33.5 ml/kg FFP. Prothrombin time, activated partial thromboplastin time and factors I-XII were measured before and after FFP infusion. Factor levels of 30 IU/dl (1 g/l for fibrinogen) were considered haemostatic. A retrospective review showed 10 of 22 (five in group 1 and five in group 2) patients had not required FFP. Of those that needed FFP, one of five in group 1 and seven of seven in group 2 had coagulation factor levels above the target post-FFP. Increments for group 1 versus 2 were: fibrinogen 0.4 vs. 1.0 g/l, FII 16 vs. 41*, FV 10 vs. 28*, FVII 11 vs. 38*, FVIII 10 vs. 17, FIX 8 vs. 28*, FX 15 vs. 37*, FXI 9 vs. 23 and FXII 30 vs. 44 IU/dl* (*P < 0.01). In vivo recovery of coagulation factors was the same for both groups and the observed increments correlated with the dose of FFP. In conclusion, coagulation screens were poor predictors of coagulation factor levels and current guidelines on the use of FFP result in predictably small increments in coagulation factors in critically ill patients and should be reviewed.