Transfusion Medicine and Hemotherapy最新文献

Introduction: Recent guidelines recommend restrictive red blood cell transfusion; therefore, hospitals have started introducing and implementing patient blood management programs. This is the first study to analyze changes in the trends of blood transfusions in the whole population over the past 10 years according to sex, age group, blood component, disease, and hospital type.

Methods: This cohort study analyzed blood transfusion records for 10 years, from January 2009 to December 2018, using nationwide population-based data from the Korean National Health Insurance Service-Health Screening Cohort database.

Results: The proportion of transfusion procedures conducted in the total population has increased constantly for 10 years. Although its proportion in the age group of 10-79 years decreased, the total number of transfusions increased significantly due to the increase in the population and proportion of transfusions in those aged 80 years or older. Furthermore, the proportion of multicomponent transfusion procedures increased in this age group, which was greater than that of transfusions. The most common disease among transfusion patients in 2009 was cancer, of which gastrointestinal (GI) cancer accounted for more than half, followed by trauma and hematologic diseases (GI cancers > trauma > other cancers > hematologic diseases). The proportion of patients with GI cancer decreased, whereas that of trauma and hematologic diseases increased over the 10 years, with trauma becoming the most common disease type in 2018 (trauma > GI cancers > hematologic diseases > other cancers). Although transfusion rates per hospitalization decreased, the total number of inpatients increased, thus increasing the number of blood transfusions in all types of hospitals.

Discussion/conclusions: The proportion of transfusion procedures in the total population increased owing to the increase in the total number of transfusions in patients aged 80 years or older. The proportion of patients with trauma and hematologic diseases has also increased. Moreover, the total number of inpatients has been increasing, which subsequently increases the number of blood transfusions performed. Specific management strategies targeting these groups may improve blood management.

Background and objectives: A sufficient supply of safe, high-quality blood components for transfusion is essential to the healthcare system in Germany. The requirements for the current reporting system are laid down in the German Transfusion Act. The present work elaborates on the advantages and limitations of the current reporting system and investigates the feasibility of a pilot project that collects specific data on blood supply based on weekly reports.

Materials and methods: Selected data on blood collection and supply from 2009 to 2021 derived from the §21 German Transfusion Act database were examined. In addition, a pilot study over a period of 12 months was conducted on a voluntary basis. The number of red blood cell (RBC) concentrates was documented and stock availability was calculated weekly.

Results: From 2009 to 2021, the annual number of RBC concentrates decreased from 4.68 to 3.43 million, the per capita distribution decreased from 58 to 41 RBC concentrates per 1,000 inhabitants. These figures did not change significantly during the COVID-19 pandemic. The data of the 1-year pilot project represented 77% of the released RBC concentrates in Germany. Percentage share of O RhD positive RBC concentrates fluctuated between 35% and 22% and for O RhD negative concentrates between 17% and 5%. The availability of O RhD positive RBC concentrate stocks varied between 2.1 and 7.6 days.

Conclusion: The data presented shows a decrease in annual RBC concentrate sales over an 11-year period and no further change over the past 2 years. A weekly monitoring of blood components detects acute problems in RBC provision and supply. Close monitoring seems helpful but should be combined with a nationwide supply strategy.

Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications.

Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products.

Key messages: Intense interaction with the stakeholders in African partner countries lead to first measurable successes in the strengthening of blood regulation, as shown here for hemovigilance.

Background: The major drug regulatory agencies have approved chimeric antigen receptor (CAR) T cells for the treatment of some B-cell lymphoproliferative diseases. Their use is expanding, and new indications will be approved. Efficient mononuclear cell collection by apheresis providing enough T cells is a critical step in further CAR T-cell manufacturing process. It is important that apheresis units are prepared for the collection of the required T cells for manufacturing with the highest efficiency and safety for the patient.

Summary: Several series have studied different characteristics that could influence the collection efficiency of T cells for CAR T-cell manufacturing. Also, an effort has been made to identify predictors of the total number of target cells collected. Despite these publications and the large number of ongoing clinical trials, consensus protocols in apheresis are scarce.

Key messages: The aim of this review was to summarize the set of measures described to optimize apheresis and ensure patient safety. Moreover, we also propose, in a practical approach, a way to apply this knowledge to the daily routine in the apheresis unit.

Introduction: Immunoadsorption (IA) of isohemagglutinins is an often-crucial procedure in preparation of major ABO blood group-incompatible living donor kidney transplantation (ABOi LDKT). Standard citrate-based anticoagulation during the procedure has potential disadvantages for distinct patient groups. In this study, we report our experience with an alternative anticoagulation scheme using heparin during IA for selected patients.

Methods: We conducted a retrospective analysis of all patients who underwent IA with heparin anticoagulation between February 2013 and December 2019 at our institution with focus on the safety and efficacy of the adapted procedure. For further validation, we compared graft function, graft survival, and overall survival with those of all recipients of living donor kidney transplants with or without pretransplant desensitizing apheresis for ABO antibodies at our institution during the same period.

Results: In thirteen consecutive patients prepared for ABOi LDKT with IA with heparin anticoagulation, no major bleeding or other significant complications were observed. All patients achieved sufficient isohemagglutinin titer reduction to proceed to transplant surgery. Graft function, graft survival, and overall survival did not significantly differ from patients treated with standard anticoagulation for IA or ABO compatible recipients of living donor kidneys.

Conclusion: IA with heparin in preparation of ABOi LDKT is safe and feasible for selected patients after internal validation.

Background: Therapeutic plasma exchange (TPE) is a well-known apheresis technology since many years and is available worldwide. Myasthenia gravis is one of the first neurological diseases successfully treated with TPE. TPE is also frequently applied in acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome). Both neurological disorders are immunologically mediated and might cause life-threatening symptoms in patients.

Summary: There is a large body of evidence from many randomized controlled trials (RCTs) that the application of TPE in myasthenia gravis crisis or in acute Guillain-Barré syndrome is effective and safe. Thus, TPE is recommended as first-line therapy with a grade 1A recommendation during the critical course of these neurological diseases. Even chronic inflammatory demyelinating polyneuropathies characterized by complement-fixing autoantibodies to myelin are successfully treated with TPE. The plasma exchange reduces inflammatory cytokines, complements activating antibodies, and leads to an improvement of neurological symptoms. TPE is no standalone treatment but often combined with immunosuppressive therapy. Recent studies (clinical trials, retrospective analysis, meta-analysis, and systematic reviews) evaluate special apheresis technology (i.e., immunoadsorption [IA], small volume plasma exchange), compare different treatments of these neuropathies, or report on the therapy of rare immune-mediated neuropathies in case reports.

Key messages: TA is a well-established treatment and is safe in acute progressive neuropathies (myasthenia gravis, Guillain-Barré syndrome) with an immune etiology. TPE has been applied for decades and thus has the best evidence so far. The indication for IA depends on the availability of that technology and the evidence by RCTs in special neurological diseases. The treatment with TA should improve the clinical outcome of patients, reducing acute or chronic (chronic inflammatory demyelinating polyneuropathies) neurological symptoms. The informed consent of the patient should carefully weight risks and benefits of the apheresis treatment and consider alternative therapies.

Introduction: Triple antibody positive antiphospholipid syndrome during pregnancy carries a poor prognosis. The placental vasculature is particularly vulnerable to these antibodies resulting in a marked increased risk of fetal growth restriction, placental infarction, abruption, stillbirth, and preterm severe preeclampsia.

Case presentation: We report a case of a primigravida with triple antibody positive antiphospholipid syndrome that demonstrated placental insufficiency and fetal compromise at a previable gestation. The patient underwent plasma exchange every 48 h for 11 weeks resulting in delivery of a viable infant. Placental blood flow was improved after complete absence of end-diastolic flow in the fetal umbilical artery.

Conclusion: Scheduled plasmapheresis every 48 h can be considered in select cases of antiphospholipid antibody syndrome.

Background: Different preparations for therapeutic plasma are available on the market. The German hemotherapy guideline has been completely updated in 2020 and, for this purpose, has reviewed the evidence for the most frequent clinical indications for the use of therapeutic plasma in adult patients.

Summary: The German hemotherapy guideline has reviewed the evidence for the following indications for the use of therapeutic plasma in the adult patient: massive transfusion and bleeding, severe chronic liver disease, disseminated intravascular coagulation, plasma exchange for TTP, and the rare hereditary FV and FXI deficiencies. The updated recommendations for each indication are discussed on the background of existing guidelines and new evidence. For most indications, the quality of evidence is low due to missing prospective randomized trials or rare diseases. However, due to the "balanced" content of coagulation factors and inhibitors therapeutic plasma remains an important pharmacological treatment option in clinical situations with an already activated coagulation system. Unfortunately, the "physiological" content of coagulation factors and inhibitors limits the efficacy in clinical scenarios with high blood losses.

Key messages: The evidence for the use of therapeutic plasma for the replacement of coagulation factors due to massive bleeding is poor. Coagulation factor concentrates seem to be more appropriate for this indication, although the quality of evidence is also low. However, for diseases with an activated coagulation or endothelial system (e.g., disseminated intravascular coagulation, TTP) the balanced replacement of coagulation factors, inhibitors, and proteases may be of advantage.

Introduction: Following the first assessment of the effects of safety measures taken against transfusion-transmitted bacterial infections (TTBI), the Paul-Ehrlich-Institut (PEI) decided to newly analyze risk minimization measures (RMM) using German hemovigilance data from 2011 to 2020, focusing on blood components, recipients, and bacterial strains.

Materials and methods: The PEI assessed the imputability of all reported serious adverse reactions (SAR) relying mainly on microbiological test results. Reporting rates (RR) of suspected, confirmed, and fatal confirmed TTBI were calculated and compared to the previous reporting 10-year period (2001-2010) using Poisson regression to estimate RR ratios (RRR). Furthermore, details on blood component age, patients' medical history, and bacterial pathogenicity were collected.

Results: With respect to the previous 10-year period, the number of suspected TTBI increased (n = 403), while fewer cases were confirmed (n = 40); the number of deaths remained more or less unchanged (n = 8). The RR for suspected TTBI were 7.9, 18.7, and 1.6 cases per million units transfused for red blood cells (RBC), platelet concentrates (PC), and fresh frozen plasma (FFP), respectively. RRR showed a statistically significant 2.5-fold increase in the RR for suspected TTBI after RBC administration from 2001-2010 to the period under review (p < 0.0001). The RR for confirmed TTBI were 0.4, 5.0, and 0.0 cases per million units transfused for RBC, PC, and FFP, respectively. Compared to the period 2001-2010, there was a statistically significant decrease in the RR of confirmed TTBI by half for PC (p = 0.0052). The RR for confirmed PC-caused TTBI with fatal outcome was 1.4 cases per million units transfused. Regardless of type of blood product transfused and outcome of SAR, the majority of TTBI occurred after administration of a product at the end of shelf life (40.0%) and to recipients of advanced age (median age: 68.5 years) and/or with severe immunosuppression (72.5%) due to decreased myelopoiesis (62.5%). 72.5% of the involved bacteria had a middle/high human pathogenicity.

Conclusion: Despite a significant decrease in confirmed TTBI following PC transfusion in Germany after implementation of RMM, the current manufacture of blood products can still not prevent TTBI with fatal outcomes. As demonstrated in various countries, RMM like bacterial screening or pathogen reduction may measurably improve the safety of blood transfusion.