Safety Of Blood Components Research Articles

Characterization of transfusion-relevant bacteria reference strains in a lyophilized format.

Blood safety measures used by blood establishments to increase blood component safety can be validated using Transfusion-Relevant Bacterial Reference Strains (TRBRS). Ultra-cold storage conditions and manual preparation of the current TRBRS may restrict their practical use. To address this issue, the ISBT Transfusion-Transmitted Infectious Diseases Working Party's Bacterial Subgroup organized an international study to validate TRBRS in a user-friendly, lyophilised format. Two bacterial strains Klebsiella pneumoniae PEI-B-P-08 and Staphylococcus aureus PEI-B-P-63 were manufactured as lyophilised material. The lyophilised bacteria were distributed to 11 different labs worldwide to assess the robustness for enumeration, identification and determination of growth kinetics in platelet concentrates (PCs). Production of lyophilised TRBRS had no impact on the growth properties compared with the traditional format. The new format allows a direct low-quantity spiking of approximately 30 bacteria in PCs for transfusion-relevant experiments. In addition, the lyophilised bacteria exhibit long-term stability across a broad temperature range and can even be directly rehydrated in PCs without losing viability. Interlaboratory comparative study demonstrated the robustness of the new format as 100% of spiked PC exhibited growth. Lyophilised TRBRS provide a user-friendly material for transfusion-related studies. TRBRS in the new format have improved features that may lead to a more frequent use in the quality control of transfusion-related safety measures in the future.

Nurses' self-efficiency levels in safe blood and blood component transfusion: The case of Turkey

ObjectiveThe study aimed to determine nurses' self-efficacy levels for safe transfusion of blood and blood components. MethodThe design of this study is descriptive and cross-sectional. Before starting the study, ethics committee approval and institution approval was obtained. The participants were informed about the purpose of the study, and their written consent was obtained. The research was conducted between the dates 01 March 2022 and 01 May 2022, a private hospital in Turkey. The study sample consisted of 482 nurses. Data were collected using descriptive characteristics form and the Safe Blood and Blood Products Transfusion Self-Efficacy Scale (SBT-SES). ResultsThe total SBT-SES scores of the nurses were high (202.7 ± 50.1), and the behavioral sub-factor self-efficacy scores were moderate (48.2 ± 19.5). When the SBT-SES scores were analyzed based on demographic characteristics, it was found that those who had received previous safe blood transfusion training scored higher than those who had not, and women scored higher than men (p < 0.05). In addition, no relationship was found between age, working time, number of weekly blood transfusions, and self-efficacy levels. DiscussionAs a result, nurses' self-efficacy levels towards blood transfusion are high. However, the behavioral sub-factor self-efficacy level is not sufficient. ConclusionBased on these results, in order to increase the behavioral self-efficacy levels of nurses, our recommendations are as follows: investigating appropriate training methods, considering the sex factor when choosing training methods and techniques, investigating the barriers to safe transfusion behaviors, and measuring self-efficacy levels at regular intervals.

Blood donation practices, processing and utilisation of blood components in government tertiary hospitals in Nigeria: a multicentre cooperative study.

Timely access to safe blood and blood components is still a challenge in Nigeria. This study aimed to determine blood donation practices, processing and utilization of blood components across government tertiary hospitals (THs) in Nigeria. This was a descriptive cross-sectional study done in Nigeria in June-July 2020. Data were analysed with SPSS version 21.0. Data were collected from 50 THs. The majority (68%) of the THs lack facilities for blood component preparation and only 18% and 32% provide cryoprecipitate and platelet concentrate, respectively. Whole blood was most commonly requested (57.04%). All facilities tested blood for HIV, HBV and HCV, but the majority (23 [46%]) employed rapid screening tests alone and nucleic acid testing was not available in any hospitals. The manual method was the most common method of compatibility testing in 90% (45/50) and none of the THs routinely perform extended red cell typing. The average time to process routine, emergency and uncross-matched requests were a mean of 109.58±79.76min (range 45.00-360.00), 41.62±25.23 (10.00-240.00) and 11.09±4.92 (2.00-20.00), respectively. Facilities for blood component preparation were not widely available. Concerned government authorities should provide facilities for blood component preparation.

Virological safety of the UK blood supply in the era of individual risk assessments and HIV PrEP.

A more individualised donor selection policy was implemented in the UK in 2021, which replaced the previous 3-month deferral for men who have sex with men (MSM). Other blood services have a variety of policies in place to ensure the virological safety of blood components, ranging from an indefinite ban on MSM, to a defined period of exclusion, or to an individualised risk assessment that is not based on gender or sexual orientation. Justification of these policies should be based on scientific evidence including assessment of lengths of virological window periods, infectious disease epidemiology within donor populations and donation screening assay sensitivities. Developments in molecular technology and assays which can detect both antibodies and antigens in the very early stages of infection have significantly reduced the risk in most developed countries. However, the increasing usage of pre-exposure prophylaxis (PrEP) to prevent acquisition of HIV infection after possible high-risk sexual contact within the UK blood donor population has been recently noted. It has brought with it new diagnostic challenges within blood screening, notably possible non-detection of HIV RNA and serological markers following PrEP use despite potential infectivity. The use of other testing strategies such as detection of HIV DNA and screening for non-declared PrEP usage should be investigated further.

A unified design for validation of methods for quality control of blood components

Quality assurance of transfusion media is a fundamental principle of the functioning of all blood service institutions, allowing guaranteeing the safety of the recipient. An integral part of the procuring process of blood components is their laboratory testing, which results reliability and reproducibility can be proved by carrying out of validation of analytical methods. The aim of the study was to define the rules for planning and carrying out validation tests of methods for quality control of blood components, including verification of their compliance with established acceptance criteria. Material and methods. The analysis of the literature about the safety of blood components and the quality of laboratory tests was carried out with an assessment of the applied significance of the information proved. Results and discussion. As a result of the work done, a unified model for confirming of the accuracy of determining of the safety indicators of transfusion media was created, which contributes to improving of the quality of donor biomaterial and the effectiveness of therapy. Conclusions. The presented validation design is relevant for medical organizations working in the sphere of blood donation and its components.

Determination of rate, causes and cost of wastage of blood and its products in two blood donation centers in Riyadh

Background and aims: Wastage of all blood products is an important issue for health providers worldwide. Optimizing blood collection and processing would reduce the rate of wastage and improve the efficiency of the blood transfusion services. The aim of this study is to determine the rate of wastage of blood and blood components and identify its reasons at two hospitals in Riyadh. Method: A retrospective study was conducted on the data retrieved from the blood donation centers records on production and wastage of blood products during the period from November 2016 to October 2017 at two hospitals in Riyadh. The data were analyzed with MS Excel and SPSS 20. Results: A total of 3220 units of whole blood were collected in both hospitals during the study period. The most prepared blood component in both hospitals was packed red blood cells (PRBCs) 96.9%, followed by fresh frozen plasma (FFP) 58.66%, and platelets (PC) 52.67%. The wastage rates for safe blood components during the study period were 3.75% for PRBCs, 6.62% for FFP, and 75.8% for Platelets. The highest wastage rate of safe blood components was for Platelets (75.8%). The major reason for that high rate was delay in getting the results of transfusion transmitted infection (TTI) tests and some units were expired before released to the blood bank. The total cost for blood wastage was 262,828.3₤ (1,201,125.33 SAR. Conclusion: This study reported the highest wastage rate for all 3 blood components in comparison with other similar studies which urge the need to take an action to reduce these occurrences.

Time Trend and Prevalence Analysis of Transfusion Transmitted Infections among Blood Donors: A Retrospective Study from 2001 to 2016.

Transfusion-transmitted infections (TTIs) remain a major threat to the patients receiving blood. The incidence of the transmission of various infectious agents has reduced ever since the introduction of various molecular techniques for detection. The study tried to figure out accurate estimates of risk and trend of TTI over a period of sixteen years, essential for monitoring the safety of blood supply and evaluating the efficacy of the currently employed screening procedures. A total of 57942 blood donors' records were analyzed for the period from January 2001 to December 2016. Chi-square test (χ2) was used to evaluate the relationship between serological positivity and particular donor characteristics. A P value of less than 0.05 was considered statistically significant. Of the 57942 donations, overall prevalence of TTI was 2.7%. Of these, the reactivity rate of hepatitis B (HBV), hepatitis C, HIV, syphilis, and malaria was 1.8%, 0.42%, 0.2%, 0.31%, and 0.017%, respectively with significant P value (P < 0.05, CI: 95%). Overall prevalence was higher in replacement donors as compared to voluntary blood donors. Trend of TTI prevalence decreased from 2001 to 2016. This epidemiological research on TTI is important for the region, as estimated disease burden based on comprehensive epidemiological research provides the foundation for public policy to ensure an easily accessible and adequate supply of safe and quality blood and blood components to the needy patients.

The analysis of indicators of functioning of blood service of the Republic of Tatarstan in 2017-2020

The actuality of donorship increases continuously since donors are the only source of blood to transfuse to patients in need. The medical institutions implementing hi-tech methods of treatment present increased requirements to quality and safety of blood components. The regular analysis of functioning of blood services permits to maintain and to develop productive potential.The article presents results of analysis of statistical indicators of blood service institutions of the Republic of Tatarstan, in particular Kazan, concerning procurement and safety of donor blood and its components as exemplified by three multidisciplinary hospitals with blood transfusion departments in 2017-2020. The data concerning number and structure of donors, donations, amount of procured blood and its components, applied technologies ensuring safety and quality of blood components is presented. The achieved indicators resulted from improved forms of donor propaganda, taking of donors with low risk of hemo-transmissible infections and coordinated work of medical personnel.

Management of blood transfusion services in low-resource countries.

Enabling universal access to safe blood components should be a key component of every country's national healthcare strategy. This study aimed to assess the current status of infrastructure and resources of blood transfusion services (BTS) in low- and middle-income countries. A cross-sectional survey was designed to gather information on blood donations, components, redistribution, testing resources and quality management systems (QMSs). The survey was distributed to the International Society of Blood Transfusion members between October 2021 and November 2021. A total of 54 respondents from 20 countries responded to the survey. This included hospital-based BTS/blood centres (46%), national blood centres (11%)and national and regional blood services (11%). Voluntary non-remunerated, replacement and paid donors accounted for 94.2%, 84.6% and 21.1% of donations, respectively. Apheresis donation was available in 59.6% of institutions. National/regional criteria for redistribution of blood components were reported by 75.9% of respondents. Blood components incurred payment charges in 81.5% of respondents' institutions, and payments were borne by patients in 50% of them. Testing methods, such as manual (83%), semi-automated (68%) or fully automated (36.2%), were used either alone or in combination. QMSs were reported in 17 institutions, while accreditation and haemovigilance were reported in 12 and 8 countries, respectively. QMS was implemented in most of the countries despite the common use of paid donations and the lack of advanced testing. Efforts to overcome persistent challenges and wider implementation of patient blood management programmes are required.

Chagas Disease and Transfusion Risk in Italy: The Results of a National Survey.

Universal serological screening in endemic areas is essential for preventing Chagas disease transmission by transfusions, while in non-endemic areas, screening is provided only to donors exposed to the infection risk. In this respect, in order to ensure high and uniform standards of quality and safety of blood components, the Italian National Blood Centre conducted a survey to detect information on management of donors at risk of Chagas disease and on the current transfusion risk. The National Blood Centre conducted a survey on preventive measures for Chagas disease in the years 2020-2021. Survey results are broadly representative of the national situation; out of 24,269 tested donors, only 15 donors were confirmed positive (0.4 out of 100,000 donors). This rate is lower than the number of positive donors (72/100,000) for transfusion transmissible infections (HIV, HBV, HCV, and T. pallidum) in the same period. Furthermore, the number of T. cruzi positive blood donors is lower than the T. cruzi positive subjects in the general population. In Italy, T. cruzi infection transfusion risk may be considered still very low, and this is confirmed by the absence of documented transfusion transmission.

INTERCEPT Pathogen Reduction in Platelet Concentrates, in Contrast to Gamma Irradiation, Induces the Formation of trans-Arachidonic Acids and Affects Eicosanoid Release during Storage.

Pathogen inactivation techniques for blood products have been implemented to optimize clinically safe blood components supply. The INTERCEPT system uses amotosalen together with ultraviolet light wavelength A (UVA) irradiation. Irradiation-induced inactivation of nucleic acids may actually be accompanied by modifications of chemically reactive polyunsaturated fatty acids known to be important mediators of platelet functions. Thus, here, we investigated eicosanoids and the related fatty acids released upon treatment and during storage of platelet concentrates for 7 days, complemented by the analysis of functional and metabolic consequences of these treatments. Metabolic and functional issues like glucose consumption, lactate formation, platelet aggregation, and clot firmness hardly differed between the two treatment groups. In contrast to gamma irradiation, here, we demonstrated that INTERCEPT treatment immediately caused new formation of trans-arachidonic acid isoforms, while 11-hydroxyeicosatetraenoic acid (11-HETE) and 15-HETE were increased and two hydroperoxyoctadecadienoic acid (HpODE) isoforms decreased. During further storage, these alterations remained stable, while the release of 12-lipoxygenase (12-LOX) products such as 12-HETE and 12-hydroxyeicosapentaenoic acid (12-HEPE) was further attenuated. In vitro synthesis of trans-arachidonic acid isoforms suggested that thiol radicals formed by UVA treatment may be responsible for the INTERCEPT-specific effects observed in platelet concentrates. It is reasonable to assume that UVA-induced molecules may have specific biological effects which need to be further investigated.

Reverse algorithm for screening of syphilis and trends in prevalence among blood donors in Coastal Karnataka.

Transfusion transmissible syphilis is caused by Treponema pallidum; blood donors are traditionally screened with non-treponemal antibody tests to ensure transfusion safety. Detection of specific antibodies against T. pallidum is employed in reverse algorithm screening. We aim to analyze the utility of the reverse algorithm screening strategy for T. pallidum and to determine the prevalence trends among blood donors in our centre. The study was conducted in a Transfusion Centre catering to the 2030 bedded Tertiary Care Centre in coastal Karnataka in two timelines from 2012 to 2014, and 2019 to 2020, respectively. A fully automated Enzyme-Linked Immunosorbent Assay and Enhanced Chemiluminescence Immunoassay, which detect both IgM and IgG antibodies against T.pallidum were used in the study. Blood donor data from 2008 to 2020 were also analyzed to observe the trend in prevalence rate of syphilis among blood donors. Among 26329 and 388 blood donors screened with ELISA and ECI, 134 (0.51%) and 9 (2.3%) were reactive to T. pallidum antibodies respectively. TPHA confirmed that 104 and 9 donors were reactive from each of the ELISA and ECI reactive donor groups. The increase in the prevalence of syphilis was observed with the use of reverse algorithm compared to the traditional strategy. The prevalence of syphilis in the present study ranged from 0.02 to 0.28%. The reverse algorithm screening can give a better result with a positive predictive value of 77.61% and 88.9% for ELISA and ECI. respectively Our study found that the use of reverse algorithm might increase the blood discard rate slightly but adds on to safety of blood components.

Source Plasma Donation: The Experience of the Iranian Blood Transfusion Organization.

Background: A declining need for red blood cells coupled with strengthening demand for plasma-derived medicines has led to a strong focus on moving whole blood donors to plasmapheresis. The purpose of this study was to evaluate the four-year policies of the Iranian Blood Transfusion Organization (IBTO) in terms of plasmapheresis recruitment of first-time donors and its effect on plasmapheresis outcome. Materials and Methods: Plasmapheresis data related to 16 centers from 2016 to 2019 was obtained from IBTO software. This information includes; (1) blood donation number, (2) plasmapheresis donation number, (3) number of plasmapheresis donors, (4) plasmapheresis donor demographic data, (5) plasmapheresis donor status, (6) frequency of plasma donation for each donor, (7) volume of plasma and (8) the prevalence of transfusion-transmissible infections (TTIs) in plasmapheresis donors. Results:The result of this study demonstrated thatplasmapheresis collection centers have recruited 85,515 (91%) first-time and 8,595(9%) regular and repeated donors from 2016 to 2019 years. Plasmapheresis to blood donation index was increased from 0.2% in 2016 to 4.9% in 2019. The mean donation number was 2 times per year. The trend of the yearly Whole Blood Donation (WBD) Index decreased from 26.69 to 24.11/1000 for the general population. The total volume of collected source plasma was 49,203 liters during this period. However, 46,000 liters of recovered plasma were decreased due to less WBD. Furthermore, the results indicated that the prevalence of HCV was significantly higher in first-time donors compared to repeated and regular donors (P = 0.000). Conclusion: It is concluded that during four years, the net volume of plasma did not increase and plasmapheresis led to reducing WBD in our country. Moreover, first-time plasmapheresis donors can be associated with challenges such as increasing screening costs and compromising the safety of plasma resources. Therefore IBTO decided to stop the project and focus on its main role to prepare safe and sufficient blood components through WB collection and also single donor platelet and concurrent plasma by plateletpheresis.

Visible 405 nm Violet-Blue Light Successfully Inactivates HIV-1 in Human Plasma.

Despite significant advances in ensuring the safety of the blood supply, there is continued risk of transfusion transmitted infections (TTIs) from newly emerging or re-emerging infections. Globally, several pathogen reduction technologies (PRTs) for blood safety have been in development as an alternative to traditional treatment methods. Despite broad spectrum antimicrobial efficacy, some of the approved ultraviolet (UV) light-based PRTs, understandably due to UV light-associated toxicities, fall short in preserving the full functional spectrum of the treated blood components. As a safer alternative to the UV-based microbicidal technologies, investigations into the use of violet-blue light in the region of 405 nm have been on the rise as these wavelengths do not impair the treated product at doses that demonstrate microbicidal activity. Recently, we have demonstrated that a 405 nm violet-blue light dose of 270 J/cm2 was sufficient for reducing bacteria and the parasite in plasma and platelets suspended in plasma while preserving the quality of the treated blood product stored for transfusion. Drawn from the previous experience, here we evaluated the virucidal potential of 405 nm violet-blue light dose of 270 J/cm2 on an important blood-borne enveloped virus, the human immunodeficiency virus 1 (HIV-1), in human plasma. Both test plasma (HIV-1 spiked and treated with various doses of 405 nm light) and control plasma (HIV-1 spiked, but not treated with the light) samples were cultured with HIV-1 permissive H9 cell line for up to 21 days to estimate the viral titers. Quantitative HIV-1 p24 antigen (HIV-1 p24) levels reflective of HIV-1 titers were measured for each light dose to assess virus infectivity. Our results demonstrate that a 405 nm light dose of 270 J/cm2 is also capable of 4–5 log HIV-1 reduction in plasma under the conditions tested. Overall, this study provides the first proof-of-concept that 405 nm violet-blue light successfully inactivates HIV-1 present in human plasma, thereby demonstrating its potential towards being an effective PRT for this blood component safety.

Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs.

In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel–Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.

Prevalence of Irregular Red Cell Antibodies in Healthy Blood Donors at a Stand-Alone Blood Centre in Gujarat

Background: Blood transfusion therapy involves multiple steps to ensure selection of safe blood component for transfusion. This includes testing for infectious markers, full ABO compatibility, free from any irregular red cell antibodies especially which are reacting at wide thermal amplitude and acceptable donor's red cell survival rates without destruction of recipient's red cells. Objective: This study was aimed to assess prevalence and type of irregular red cell antibodies in a large number of blood donor population at a standalone blood centre in Gujarat. Methods: This retrospective observational study included blood donor samples for antibody screening from January 2018 to March 2022. A total of 2,16,576 healthy blood donors including 2,00,493 (92.57%) males and 16,083 (7.43%) females were screened. Results: The prevalence of irregular red cell antibodies was 0.03 per cent in our donor population. Of the total 66 donors with red cell antibodies, 53(80.30%) had alloantibodies, 8(12.12%) had autoantibodies and 6 donors (9.09%) showed positive antibody screening with inconclusive results. We also found one case of cold antibody. Conclusion: Alloimmunization to red cell antigens is a challenging task for current transfusion practices. The antibody screening in blood donors may improve the quality and safety of blood transfusion in the recipients. It also reduces the risk of complications from incompatible blood transfusions. Keywords: antibody screening, allo-antibody identification, autoantibody, safe blood transfusion, hemolytic transfusion reaction.

Internal quality control of blood &amp; blood components - Two years study at a standalone blood centre, Ahmedabad

Internal Quality Control (IQC) describes steps taken by the blood centre to ensure that tests are performed correctly and as per the guidelines. Primary goal of Quality Control is transfusion of safe quality of blood components to give optimal benefit to patients. The aim of study was to ensure supply of safe and efficient blood component to patients.Quality control of blood components prepared between December 2019 to November 2021 were included in our study. Monthly Quality control (QC) of the blood components were done as per the national guideline, 1% of total components prepared or minimum 4 units. Packed red cell units were evaluated for haematocrit, random donor platelet concentrates for yield and fresh frozen plasma (FFP) and cryoprecipitate were evaluated for volume, factor VIII and fibrinogen concentrations.A total of 1302 units were tested for IQC. The mean hematocrit of RBC was 58.8%. In PLT, mean yield was 6.9 × 10/cu mm. Mean factor VIII and fibrinogen levels were found to be 377 IU/bag and 851.60 mg/bag in FFP respectively. Mean factor VIII and fibrinogen levels were found to be 311.81 IU/bag and 1694.4 mg/bag in cryoprecipitate respectively.In the present era, Quality Control is very important step in maintaining quality of blood components and the quality objectives of the blood centre, so that we ensure most efficient blood transfusion to patient. The IQC of blood components at our blood centre is in overall compliance and met recommended national standards. Implementation of standard operating procedures, accomplishment of standard guidelines, proper documentation with regular audit and staff competencies can improve the quality performance of the transfusion services.

Whole blood versus red cell concentrates for children with severe anaemia: a secondary analysis of the Transfusion and Treatment of African Children (TRACT) trial

SummaryBackgroundThe TRACT trial established the timing of transfusion in children with uncomplicated anaemia (haemoglobin 4–6 g/dL) and the optimal volume (20 vs 30 mL/kg whole blood or 10 vs 15 mL/kg red cell concentrates) for transfusion in children admitted to hospital with severe anaemia (haemoglobin <6 g/dL) on day 28 mortality (primary endpoint). Because data on the safety of blood components are scarce, we conducted a secondary analysis to examine the safety and efficacy of different pack types (whole blood vs red cell concentrates) on clinical outcomes.MethodsThis study is a secondary analysis of the TRACT trial data restricted to those who received an immediate transfusion (using whole blood or red cell concentrates). TRACT was an open-label, multicentre, factorial, randomised trial conducted in three hospitals in Uganda (Soroti, Mbale, and Mulago) and one hospital in Malawi (Blantyre). The trial enrolled children aged between 2 months and 12 years admitted to hospital with severe anaemia (haemoglobin <6 g/dL). The pack type used (supplied by blood banks) was based only on availability at the time. The outcomes were haemoglobin recovery at 8 h and 180 days, requirement for retransfusion, length of hospital stay, changes in heart and respiratory rates until day 180, and the main clinical endpoints (mortality until day 28 and day 180, and readmission until day 180), measured using multivariate regression models.FindingsBetween Sept 17, 2014, and May 15, 2017, 3199 children with severe anaemia were enrolled into the TRACT trial. 3188 children were considered in our secondary analysis. The median age was 37 months (IQR 18–64). Whole blood was the first pack provided for 1632 (41%) of 3992 transfusions. Haemoglobin recovery at 8 h was significantly lower in those who received packed cells or settled cells than those who received whole blood, with a mean of 1·4 g/dL (95% CI –1·6 to –1·1) in children who received 30 mL/kg and –1·3 g/dL (–1·5 to –1·0) in those who received 20 mL/kg packed cells versus whole blood, and –1·5 g/dL (–1·7 to –1·3) in those who received 30 mL/kg and –1·0 g/dL (–1·2 to –0·9) in those who received 20 mL/kg settled cells versus whole blood (overall p<0·0001). Compared to whole blood, children who received blood as packed or settled cells in their first transfusion had higher odds of receiving a second transfusion (odds ratio 2·32 [95% CI 1·30 to 4·12] for packed cells and 2·97 [2·18 to 4·05] for settled cells; p<0·001) and longer hospital stays (hazard ratio 0·94 [95% CI 0·81 to 1·10] for packed cells and 0·86 [0·79 to 0·94] for settled cells; p=0·0024). There was no association between the type of blood supplied for the first transfusion and mortality at 28 days or 180 days, or readmission to hospital for any cause. 823 (26%) of 3188 children presented with severe tachycardia and 2077 (65%) with tachypnoea, but these complications resolved over time. No child developed features of confirmed cardiopulmonary overload.InterpretationOur study suggests that the use of packed or settled cells rather than whole blood leads to additional transfusions, increasing the use of a scarce resource in most of sub-Saharan Africa. These findings have substantial cost implications for blood transfusion and health services. Nevertheless, a clinical trial comparing whole blood transfusion with red cell concentrates might be needed to inform policy makers.FundingUK Medical Research Council (MRC) and the Department for International Development.TranslationFor the French translation of the abstract see Supplementary Materials section.

Analysis of Blood and Blood Component Wastage and its Reasons among Various Departments in a Tertiary Care Teaching Hospital in Southern India

Introduction: The main aim of many blood centers are to supply sufficient amount of safe blood and blood components whenever required. Shortage of blood may be due to low donation rate, inadequate storage, improper transportation and wastage at ward side. Wastage of blood can have a negative impact on blood transfusion services. Aim: To determine the rates of wastage of blood and blood components units at the ward side and identify the various reasons for wastage and explain the strategies to reduce the wastage rate. Materials and Methods: This retrospective study was conducted in the Department of Transfusion Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India from January 2018 to December 2020. The data was collected from the blood centre record. All blood and blood components issued during the study period were included in the study. The number, type and blood group of blood and blood components issued, the number of blood units wasted after issue, and the reason for wastage was collected. The collected data were entered in Microsoft excel and analysed using Statistical Package for the Social Science (SPSS) version 21.0. Descriptive statistics were performed as necessary. Results: During the study period, a total of 69198 units of blood and blood components were issued to different wards and operation theatres in the hospital. Among the total issues, 26863 (38.82%) were in the form of Packed Red Blood Cells (PRBC), 3968 (5.73%) in the form of Whole Blood (WB), 26069 (37.67%) in the form of Fresh Frozen Plasma (FFP), 11272 (16.29%) in the form of Random Donor Platelets (RDP), 933 (1.35%) in the form of Cryoprecipitate (CP) and 93 (0.13%) in the form of Single Donor Platelets (SDP). Among issued, 115 (0.17%) of blood and blood components were wasted with packed red cells accounting for 51 (44.35%). Among the various reasons, 43 (37.39%) was due to demise of patients before transfusion was initiated, followed by non requirement by the patients due to no loss/minimal loss blood during surgery 24 (20.87%). Majority of blood and blood components were wasted by the Department of Emergency Medicine (EMD) 36 (31.3%) followed by the Department of Neurology 20 (17.39%) and Orthopaedics 12 (10.43%). Conclusion: Implementation of proper blood transfusion policies and continuous educational programs in coordination with clinicians and staff nurses at ward side and operation theatres will help to decrease the blood wastage at ward side.

Molecular validation of pathogen-reduction technologies using rolling-circle amplification coupled with real-time PCR for torquetenovirus DNA quantification.

Pathogen reduction technologies (PRT) based on nucleic-acid damaging chemicals and/or irradiation are increasingly being used to increase safety of blood components against emerging pathogens, such as convalescent plasma in the ongoing COVID-19 pandemic. Current methods for PRT validation are limited by the resources available to the blood component manufacturer, and quality control rely over pathogen spiking and hence invariably require sacrifice of the tested blood units: quantitative real-time PCR is the current pathogen detection method but, due to the high likelihood of detecting nonviable fragments, requires downstream pathogen culture. We propose here a new molecular validation of PRT based on the highly prevalent human symbiont torquetenovirus (TTV) and rolling circle amplification (RCA). Serial apheresis plasma donations were tested for TTV before and after inactivation with Intercept® PRT using real-time quantitative PCR (conventional validation), RCA followed by real-time PCR (our validation), and reverse PCR (for cross-validation). While only 20% of inactivated units showed significant decrease in TTV viral load using real-time qPCR, all donations tested with RCA followed by real-time PCR showed TTV reductions. As further validation, 2units were additionally tested with reverse PCR, which confirmed absence of entire circular genomes. We have described and validated a conservative and easy-to-setup protocol for molecular validation of PRT based on RCA and real-time PCR for TTV.