Haemolytic transfusion reactions caused by non-ABO red cell antibodies reported to the Norwegian Haemovigilance System 2004-2020.

BACKGROUND AND OBJECTIVES: The aim of this study was to analyse the reports received in the Norwegian Haemovigilance System from 2004 to 2020 on acute and delayed haemolytic transfusion reactions caused by non-ABO red cell antibodies. MATERIALS AND METHODS: Antibody specificity, clinical symptoms and outcomes were included when available. RESULTS: After transfusion of 3.7 million red cell concentrates, reports on 78 cases of haemolytic transfusion reactions caused by non-ABO red cell antibodies were received, corresponding to an incidence of 1 in 47,000 transfused red cell concentrates. There were 30 acute and 48 delayed haemolytic transfusion reactions. A total of 113 red cell antibodies were found: 82 alloantibodies, 6 autoantibodies and 25 cases where the antibody specificity could not be determined. Two fatalities occurred: one caused by anti-Wra and one caused by an unidentified red cell antibody. The most frequently reported antibody specificities were those in the Rh and Kidd blood group systems, representing 24% and 14%, respectively, of all the antibodies identified. In six cases, errors occurred, leading to the issuing of blood units without the required phenotype match. CONCLUSIONS: Despite the possible underreporting, the low number of serious haemolytic transfusion reactions reflects an adequate pre-transfusion practice by the Norwegian blood banks.

Irradiation to prevent a fatal transfusion complication. / Bestråling for å hindre en fatal transfusjonskomplikasjon.

Cellular blood components should be irradiated as a preventive measure against transfusion-associated graft-versus-host disease in severely immunocompromised patients.

The Norwegian experience with nationwide implementation of fetal RHD genotyping and targeted routine antenatal anti-D prophylaxis.

OBJECTIVES: To reduce the risk of RhD alloimmunization during the last trimester of pregnancy, a targeted routine antenatal anti-D prophylaxis (RAADP) programme was implemented in Norway in 2016. Here, we present and discuss our experience with the nationwide implementation of the programme, and report sample uptake and preliminary data of de novo anti-D in pregnancy. BACKGROUND: The targeted RAADP was advised by the academic community and evaluated by the health authorities. A National Working Group has conducted the implementation in the transfusion services and contributed to organise the administration of the antenatal anti-D prophylaxis. Fetal RhD type is determined by non-invasive prenatal testing at gestational week 24, and anti-D prophylaxis is administrated at gestational week 28 only to women with RhD positive fetuses. METHODS: We describe the implementation process of targeted RAADP in Norway. The sample uptake is calculated by comparing the number of fetal RHD screens with the expected number of samples. RESULTS: The sample uptake shows regional variations: 88%-100% after 3 years. Promising decrease in de novo anti-D detected during pregnancy is observed. CONCLUSIONS: Nationwide targeted RAADP is implemented and included in the Norwegian maternity care programme. Compliance to sample uptake should further improve in some regions. A remaining issue to fulfil is the documentation of the accuracy of the fetal RHD-typing at all sites. Post-natal prophylaxis will then be guided by the fetal RHD result. Dedicated registries will ensure data to evaluate the expected reduction in pregnancy-related RhD immunisations, which is the final success criterion of the programme.

[Thromboelastography - useful in cases of bleeding?] / Tromboelastografi ­ nyttig når det blør?

Blood products are a limited resource. A number of studies have shown that the use of thromboelastography (TEG) may reduce the need for blood transfusions. The analysis can be used in acute situations in patients with massive haemorrhage as a guide to transfusion therapy. Use of TEG may play an important role in targeting transfusion therapy.

Tromboelastography: variability and relation to conventional coagulation test in non-bleeding intensive care unit patients.

BACKGROUND: Intensive care unit (ICU) patients usually have abnormal biochemical and hematological laboratory test results as a consequence of organ dysfunction and underlying disease. Thromboelastography (TEG®) is a point-of-care laboratory analysis that gives an overview of several aspects of the coagulation process. In order to be able to perform a clinical interpretation of abnormal TEG® results the expected values from non-bleeding ICU patients should be known. The aim of this study is to report the normal variability observed in non-bleeding, non-transfused ICU patients. METHODS: Adult ICU patients without bleeding in the last 24 hours, who had not received blood products within the last 24 hours, with no hematological diseases and no anticoagulation therapeutic treatment were included. Standard clinical chemistry tests, coagulation tests and TEG® were obtained. All results were reported in relation to standard reference values. TEG® values were compared with routine coagulation measurement using Spearman correlations. RESULTS: We observed that the normal variability observed in non-bleeding, non-transfused ICU patients in this study included abnormally high TEG® values for maximum amplitude (MA) (73%). None of the patients showed MA results corresponding to hypocoagulability. Other coagulation tests were also changed with elevated D-Dimer, fibrinogen and APTT values, and a low ATIII value. CONCLUSION: In unselected ICU patients without bleeding or known factors that influence coagulation, a TEG® value of MA is often elevated suggesting hypercoagulability. This finding should be considered when interpreting TEG® observations obtained in ICU patients.

What is happening? The evolving role of the blood bank in the management of the bleeding patient: The impact of TEG as an early diagnostic predictor for bleeding.

Despite recent advances in the understanding and treatment of coagulopathy, the management of the bleeding patient remains as a major challenge. Traditionally, the main task of the blood bank has been to guarantee the supply of high quality blood and blood components/products to the hospital. Decisions regarding the use of blood components have always been the clinicians' responsibility, with little active involvement of the transfusion service. In the last years, many hospitals have implemented the use of "acute transfusion packages" for massively bleeding patients and point-of-care (POC) instruments such as TEG and RoTEM for monitoring coagulation status in this patient group. This, in addition to the implementation of patient blood management programs in the hospitals, has led to an increasing involvement of transfusion medicine specialists in transfusion decision making, especially regarding strategies for monitoring and treatment of the massively bleeding patient. This new trend may contribute to a more optimal management and monitoring of the bleeding patient, as POC testing may be used as an early predictor for blood usage. The blood bank should optimise the use of POC testing to provide accurate information in a cost-effective way.

Comparison of three point-of-care testing devices to detect hemostatic changes in adult elective cardiac surgery: a prospective observational study.

BACKGROUND: Bleeding complications in cardiac surgery may lead to increased morbidity and mortality. Traditional blood coagulation tests are not always suitable to detect rapid changes in the patient's coagulation status. Point-of-care instruments such as the TEG (thromboelastograph) and RoTEM (thromboelastometer) have been shown to be useful as a guide for the clinician in the choice of blood products and they may lead to a reduction in the need for blood transfusion, contributing to better patient blood management. METHODS: The purpose of this study was to evaluate the ability of the TEG, RoTEM and Sonoclot instruments to detect changes in hemostasis in elective cardiac surgery with cardiopulmonary bypass and to investigate possible correlations between variables from these three instruments and routine hematological coagulation tests. Blood samples from thirty-five adult patients were drawn before and after surgery and analyzed in TEG, RoTEM, Sonoclot and routine coagulation tests. Data were compared using repeated measures analysis of variance and Pearson's test for linear correlation. RESULTS: We found significant changes for all TEG variables after surgery, for three of the RoTEM variables, and for one variable from the Sonoclot. There were significant correlations postoperatively between plasma fibrinogen levels and variables from the three instruments. CONCLUSIONS: TEG and RoTEM may be used to detect changes in hemostasis following cardiac surgery with CPB. Sonoclot seems to be less suitable to detect such changes. Variables from the three instruments correlated with plasma fibrinogen and could be used to monitor treatment with fibrinogen concentrate.

Eight years with haemovigilance in Norway. What have we learnt?

The purpose of a haemovigilance system is to identify complications related to transfusion or blood donation, analyze them and learn in order to avoid complications in the future. The Norwegian Haemovigilance System (Troll) started as a voluntary, professionally led reporting system in 2004. In 2007 haemovigilance became an authority task, according to the EU blood directive, and reporting of serious adverse reactions and serious adverse events became mandatory. The Norwegian Directorate of Health became responsible for the system and asked The Norwegian Knowledge Centre for the Health Services to run it. Results from the first eight years of reporting are presented. A total of 2607 transfusion complications or incorrect blood component transfused (IBCT) have been reported (127 per 100,000 transfusions). Most transfusion reactions are mild. The most frequently reported are febrile non-hemolytic and mild allergic reactions. Serious adverse reactions such as anaphylaxis, TRALI and hemolytic transfusion reactions occur, but are rare. One incident of bacterial transmission and four incidents of viral transmission have been reported, among them one case of HCV transmission. No incidents of transmission of HIV or hepatitis B have been reported. IBCT was reported 168 times. Our data are comparable with data from other countries. Recommendations from the haemovigilance system are included in local and national guidelines. Increased knowledge of haemovigilance among physicians and nurses can lead to improved transfusion safety. It is safe to receive blood in Norway, but serious adverse reactions do occur. Our reporting system seems to be well accepted. We have not yet been able to document any change of practice that has lead to a reduction in the number of complications.

A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment.

BACKGROUND: Inactivation of pathogens and white blood cells in platelet (PLT) components with amotosalen and UVA light (INTERCEPT, Cerus Europe BV) has entered clinical practice in European blood centers. A prospective cohort study was implemented to characterize the safety profile of this new PLT component in a broad patient population. STUDY DESIGN AND METHODS: Apheresis or buffy-coat PLT components were leukoreduced, suspended in approximately 35 percent plasma and 65 percent PLT additive solution, and treated with the INTERCEPT process. Blood centers were requested to complete a safety data form after each transfusion. RESULTS: Data for 5106 INTERCEPT components administered to 651 patients were monitored. A total of 5051 (98.9%) transfusions and 609 (93.5%) patients had no reported reactions. Fifty-five (1.1%) transfusions were associated with adverse events, and 42 (0.8%) were possibly, probably, or related to the PLT transfusion. Adverse events occurred in 42 (6.4%) patients, but in only 32 (4.9%) patients was a causal relationship to PLT transfusion established. One reaction was serious, and no deaths were related to PLT transfusion. Among the transfusions reactions, the most frequent clinical events in descending frequency were chills, fever, dermatologic reactions, dyspnea, nausea or vomiting, and hypotension. No episodes of transfusion-related acute lung injury were reported. CONCLUSIONS: In this cohort study, 99.2 percent of transfusions were without reactions attributed to PLTs. INTERCEPT PLTs exhibited a safety profile similar to that previously reported for conventional PLT components.