Vox Sanguinis最新文献

Plasma-derived medicinal products (PDMPs) are recognized internationally as essential medicines required to treat various acute and chronic conditions including congenital deficiencies of plasma proteins in haemophilia and primary immune deficiency. Global provision of these medicines is dominated by a small number of commercial companies, influencing the price and availability of the products. Achieving a level of strategic independence from this dominance is now seen as a public health priority in many countries. During the Regional Congress of the International Society for Blood Transfusion (ISBT) in Cape Town, South Africa, in November 2023, around 50 delegates from 24 countries participated in a workshop (WS) organized jointly by the International Plasma and Fractionation Association (IPFA) and the ISBT Working Party on Global Blood Safety on pathways towards provision of PDMPs from domestic plasma independent of commercial purchase in the open market. The WS was structured around three themes, each addressed by a separate group: Quality/safety requirements for plasma for fractionation (PfF) Stepwise access for safe plasma proteins Approaching contract fractionation A synthesis of conclusions from these groups included the following: The need to acquire support from government authorities for a national plasma policy, recognizing the difficulties posed by unstable political and bureaucratic environments. The value of embedding plasma and PDMPs within a patient blood management (PBM) paradigm to promote optimal clinical use of PDMPs. Training of blood/plasma collection personnel in the relevant principles of Good Manufacturing Practice (GMP), coupled with regulatory oversight of plasma product production in the engaged jurisdictions. Appreciation that limited access to contract fractionation may necessitate a stepwise approach, which may include small-scale preparation of versions of essential plasma proteins as an intermediate phase towards the manufacture of industrial-scale PDMPs from domestic plasma.

Background and objectives: This work provides an overview of the incentives used for plasma donation in Europe and beyond. The overview can provide new ideas to blood establishments.

Materials and methods: We conducted a systematic online search of incentives used and asked national experts to validate the data across all European Union countries as well as other European and non-European countries. We categorized the data into level of incentive (using the Nuffield Council on Bioethics' rungs [2011]) and country.

Results: We analysed more than 490 organizations across 26 countries. Our findings reveal different incentives used in these countries. Snacks and pre-donation health checks are commonly provided. In addition, loyalty programmes, small gifts, vouchers, lotteries, travel compensations and time off from work extend the strategic incentive portfolio. Only seven countries offer financial compensation ranging from the equivalent of 10-35€ for European countries. In countries with a decentralized model, where more than one organization collects plasma, we observe that more diversified incentive strategies are generally used, including monetary and non-monetary incentives. In countries with a centralized model, where only one organization is allowed to collect plasma, financial compensation is usually not offered. Centralized plasma collection without financial compensation relies on a wider range of non-monetary incentives than with financial compensation.

Conclusion: The country group analysis offers valuable insights into the relationship between incentive strategies and the prevailing centralized versus decentralized plasma collection model. This overview provides a broader understanding of incentives used by blood establishments and offers avenues for future practice.

Certain therapies that target CD markers on some blood cells can affect pretransfusion testing. Key examples are anti-CD38, CD47 monoclonal antibody (mAb) therapies such as daratumumab (DARA) and magrolimab, which have presented a challenge for transfusion medicine laboratories around the globe. Scientists have been faced with not only introducing a protocol to provide safe blood to patients but also investigating the most effective method to remove the pretransfusion pan-agglutinating interference caused. A number of papers in the last 5 years have reported on various methods to remove pretransfusion interference; however, most of these studies have been conducted only in a few countries. Most recent reviews on this topic have focused on techniques and reagents to remove pretransfusion interference, and dithiothreitol is currently the gold standard for removing DARA interference. However, it was clear from this review that while many laboratories have developed processes for addressing interference in pretransfusion testing, and DARA interference may not be a major issue, there are still laboratories around the world, that may not have adequately addressed this issue. In addition, the impact of mAb interference on widely used techniques such as flow cytometry is unclear.

Background and objectives: E-learning programmes are increasingly offered in transfusion medicine (TM) education. The aim of this study was to explore facilitators and barriers to TM e-learning programmes, including assessment of learning outcomes and measures of effectiveness.

Materials and methods: Participants selected from a prior survey and representing a diverse number of international e-learning programmes were invited to participate. A mixed methodology was employed, combining a survey and individual semi-structured one-on-one interviews. Interview data were analysed inductively to explore programme development, evaluation, and facilitators and barriers to implementation.

Results: Fourteen participants representing 13 institutions participated in the survey and 10 were interviewed. The e-learning programmes have been in use for a variable duration between 5 and 16 years. Funding sources varied, including government and institutional support. Learner assessment methods varied and encompassed multiple-choice-questions (n = 12), direct observation (n = 4) and competency assessment (n = 4). Most regional and national blood collection agencies rely on user feedback and short-term learning assessments to evaluate their programmes. Only one respondent indicated an attempt to correlate e-learning with clinical practices. Factors that facilitated programme implementation included support from management and external audits to ensure compliance with regulatory educational and training requirements. Barriers to programme implementation included the allocation of staff time for in-house development, enforcing compliance, keeping educational content up-to-date and gaining access to outcome data for educational providers.

Conclusion: There is evidence of considerable diversity in the evaluation of e-learning programmes. Further work is needed to understand the ultimate impact of TM e-learning on transfusion practices and patient outcomes.

Background and objectives: To evaluate the severity of haemolytic disease of the foetus and newborn (HDFN) in subsequent pregnancies with RhD immunization and to identify predictive factors for severe disease.

Materials and methods: Nationwide prospective cohort study, including all pregnant women with RhD antibodies. All women with at least two pregnancies with RhD antibodies and RhD-positive foetuses were selected. The main outcome measure was the severity of HDFN in the first and subsequent pregnancy at risk. A subgroup analysis was performed for the group of women where RhD antibodies developed after giving birth to an RhD-positive child and thus after receiving anti-D at least twice (group A) or during the first pregnancy at risk for immunization (group B).

Results: Sixty-two RhD immunized women with a total of 150 RhD-positive children were included. The severity of HDFN increased for the whole group significantly in the subsequent pregnancy (p < 0.001), although it remained equal or even decreased in 44% of women. When antibodies were already detected at first trimester screening in the first immunized pregnancy, after giving birth to an RhD-positive child (group A), severe HDFN in the next pregnancy was uncommon (22%). Especially when no therapy or only non-intensive phototherapy was indicated during the first immunized pregnancy (6%) or if the antibody-dependent cell-mediated cytotoxicity result remained <10%. Contrarily, women with a negative first trimester screening and RhD antibodies detected later during the first pregnancy of an RhD-positive child (group B), often before they had ever received anti-D prophylaxis, were most prone for severe disease in a subsequent pregnancy (48%).

Conclusion: RhD-mediated HDFN in a subsequent pregnancy is generally more severe than in the first pregnancy at risk and can be estimated using moment of antibody detection and severity in the first immunized pregnancy. Women developing antibodies in their first pregnancy of an RhD-positive child are at highest risk of severe disease in the next pregnancy.

Background and objectives: In May 2022, the United Kingdom reported the first case of chained transmission of the monkeypox (mpox) virus without any known epidemiological links to west or central Africa. The monthly number of mpox patients currently has passed a peak and is declining globally, and infected patients include both non-vaccinated and vaccinated individuals. Herein, the virus-neutralizing (VN) activity against vaccinia viruses, which are considered to cross-react with the mpox virus, in the intravenous immunoglobulin (IVIG) lots derived from donors, including vaccinated Japanese populations, was evaluated to clarify the status of the Japanese blood donor population.

Materials and methods: VN titres against vaccinia and human mpox viruses in IVIG lots derived from donors in Japan and the United States manufactured between 1999 and 2021 and 1995 and 2001, respectively, were evaluated by neutralization testing.

Results: VN titres of IVIG derived from donors in Japan and the United States against vaccinia and mpox viruses showed a slowly decreasing trend between 1999 and 2021.

Conclusion: VN titres are expected to decrease in the future since the percentage of vaccinated donors in the donor population seems to have decreased. Therefore, continuous monitoring of VN titres is required.

Background and objectives: A plasma transfusion dose should be weight-based (10-20 mL/kg), which equates to three to four units in an average-sized adult; therefore, the transfusion of single units under most circumstances is sub-therapeutic.

Materials and methods: This retrospective observational study examined the prevalence of single-unit plasma transfusion in adults within a 12-hospital system from 1 January 2018, to 31 December 2019.

Results: During the study period, 5791 patients received plasma transfusions. The overall prevalence of single-unit plasma was 17.1% for 988 patients. The majority, 3047 (52.6%), occurred at one hospital, 2132 (36.9%) among five hospitals and 612 (10.7%) at the remaining six hospitals. Cardiac and gastrointestinal (GI)/transplant transfused 2707 (46.8%), combined respiratory, neurological, orthopaedic and congenital/dermatology/other comprised 2133 (36.9%) of the six hospitals that transfused less than 200 patients, four (66.7%) transfused single units above the overall prevalence.

Conclusion: In this hospital system, more than one in six patients received a transfusion of a single plasma unit. Six of the 12 hospitals had 89.5% of the patients who were transfused plasma. Six service lines transfused 83.7% of all patients receiving plasma. Hospitals that infrequently transfused plasma were more likely to under-dose.

Background and objectives: The detection of treponemal antibodies, which are used to make a diagnosis of syphilis, is important both for diagnostic purposes and as a mandatory blood donor test in most countries. We evaluated the feasibility of using Kode Technology to make syphilis peptide red cell kodecytes for use in column agglutination serologic platforms.

Materials and methods: Candidate Kode Technology function-spacer-lipid (FSL) constructs were made for the Treponema pallidum lipoprotein (TmpA) of T. pallidum, using the peptide and FSL selection algorithms, and then used to make kodecytes. Developmental kodecytes were evaluated against a large range of syphilis antibody reactive and non-reactive samples in column agglutination platforms and compared against established methodologies. Overall, 150 reactive and 2072 non-reactive Syphicheck assay (a modified T. pallidum particle agglutination) blood donor samples were used to evaluate the agreement rate of the developed kodecyte assay.

Results: From three FSL-peptide candidate constructs, one was found to be the most suitable for diagnostics. Of 150 Syphicheck assay reactive samples, 146 were TmpA-kodecyte reactive (97.3% agreement), compared with 58.0% with the rapid plasmin reagin (RPR) assay for the same samples. Against the 2072 expected syphilis non-reactive samples the agreement rate for TmpA-kodecytes was 98.8%.

Conclusion: TmpA-kodecytes are viable for use as cost-effective serologic reagent red cells for the detection of treponemal antibodies to diagnose syphilis with a high level of specificity in blood centres. This kodecyte methodology also potentially allows for introduction of the reverse-algorithm testing into low-volume laboratories, by utilizing existing transfusion laboratory infrastructure.

Background and objectives: Transfusion-related acute lung injury is an infrequent adverse reaction observed in patients receiving blood products. The lung injury can range in severity and can be associated with both mortality and mortality. All blood products except albumin have been linked to cases of transfusion-related acute lung injury. In fact, albumin may be used as a salvage modality in severe transfusion-related acute lung injury. We report an alcoholic patient who developed lung injury following treatment with albumin in the setting of hypoalbuminaemia.

Materials and methods: A 41-year-old male with alcoholic liver disease was admitted for severe ascites and alcoholic hepatitis. Chest x-ray showed small pleural effusions at the lung bases with no overt pulmonary oedema. He received high doses of furosemide for lower extremity oedema. The patient received a total of two albumin infusions to augment the diuresis effect.

Results: He subsequently developed acute hypoxic respiratory failure with imaging showing interstitial and airspace abnormalities concerning for pulmonary oedema. He showed no additional signs of volume overload and was treated supportively until the condition improved.

Conclusion: This is the first reported case of albumin-associated lung injury proximally related to albumin infusion. We aim to increase awareness of this possible sequelae among physicians.