bluuebunny/crossref_metadata_2025_split huggingface dataset:
Blood Supply Management: Experience and recommendations from Australia
Authors: Caulfield J. 
Published: May 2013

AbstractBackgroundThis paper provides an overview of the Australian experience of Blood Supply Management (BSM), through analysis of each of the five steps of BSM as agreed by the ISBT BSM working group. The steps are as follows:

Assess past hospital Red Blood Cell (RBC) use for patients.
Establish Forecast for overall annual supply for Blood Establishments (BEs) and use (for hospitals).
BEs: Establish annual Blood Collection/Donor base/Supply Programme.
Weekly balancing Whole Blood (WB)/RBC use (demand) and supply in BE(s)/RBC supplier(s) and Hospitals.
Assessing and updating the patients' RBC needs and their satisfaction (self‐sufficiency/partial sufficiency/oversufficiency) from Voluntary Non Remunerated Blood Donors (VNRBD) (%).
Successes and challenges associated with this approach in the Australian context are outlined.ResultsImplementation of the Sales and Operations Planning (S&OP) framework has been key to improving BSM. S&OP provides a comprehensive continuous improvement approach to BSM that is embedded in Blood Service processes. The positive results are evident in key metrics:

8% increase in order fulfillment in the last 3 years;
Increasing productivity;
Decreasing capital investment requirements;
Decreased supply volatility;
Decreased product wastage; and
Improved efficiency.
Challenges for BSM in Australia include:

Logistics challenges posed by the geographically sparse Australian population;
Disproportionately high demand for Rhesus negative red cells comparative to the Rhesus negative members of the Australian population, requiring a donor panel that is not representative of blood type population distribution;
The time lag between a decision to take corrective action (in the form of marketing, public relations and call centre activity) by the Inventory Response Team and the observed improvement in inventory levels; and
Inability to import components from overseas, except for rare phenotypes.
ConclusionThe introduction of S&OP at the Blood Service has resulted in significant BSM improvements, including more accurate demand and supply forecasting and resulting improvements in productivity, order fulfillment, product wastage and overall efficiency.
Blood supply management – experience and recommendations from Africa
Authors: Mpuntsha L. , Reddy R. 
Published: May 2013

The background is the need to understand the challenges of achieving sufficient blood supply in Africa. The aim is to show that a lot can be achieved with good systems and adequate resources applied.The Materials & Methods is reporting on the blood supply data systems used to analyse and manage blood collection and distribution in SANBS. The results show that with use of data a good system can be developed. The conclusion reflects the need to share information accross Africa.
Update on pathogen reduction technology
Authors: Custer B. 
Published: May 2013

BackgroundThe development and adoption of pathogen reduction technology (PRT) continues. The ability to reduce transmission of a broad range of infectious and non‐infectious threats remains the primary reason PRT is attractive.AimThe objective of this update is to review recent findings in the development of the three most widely available PRT methods for labile blood components.MethodsThe update uses important recent publications to bring to attention new findings, current clinical studies being conducted and data from routine use in countries where regulatory approval has been obtained.ResultsTerumoBCT Mirasol™ – Recent clinical research on Mirasol‐treated platelets and plasma PRT has focused on studies that quantify the performance of white blood cell inactivation, with strong evidence of advantages over gamma irradiation. Published research on whole blood PRT currently in development provides evidence of pathogen reduction, white cell inactivation and reduction in antigen expression. Mirasol‐treated platelets are in routine use in 18 countries and plasma in routine use in 11 countries.Macopharma Theraflex™ – Initial success in developing a novel procedure that uses short‐wave ultraviolet light (UVC) without addition of a photoactive chemical to treat platelets has been reported and is currently being evaluated for safety and efficacy. Based on haemovigilance data for methylene blue (MB)‐treated plasma, a significantly higher incidence of severe allergic reactions or other adverse events in comparison with other fresh frozen plasma types could not be confirmed. Theraflex MB‐treated plasma is in routine use in 15 countries.Cerus Intercept™ – Efforts to understand the impact of Intercept‐treated platelets based on proteomic analyses have been reported, and the overall interpretation of proteomic findings is that although some minor changes are evident, there is no indication or evidence for a potential clinical concern for transfusion recipients. Other areas of active research focus on the inactivation of RBC concentrates using the second generation treatment process with S‐303. Intercept‐treated platelets are in routine use in 21 countries and plasma in routine use in 12 countries.ConclusionBoth controlled clinical studies and post‐marketing surveillance are necessary to further establish the safety and effectiveness of each PRT method. Recent evidence does not suggest an obvious safety threat for any of the current PRT methods in routine use. The relative value in terms of patient health and health economics, including cost‐utility, of these methods in terms of health gains achieved by PRT remain insufficiently studied.
Application validation versus infrastructure qualification
Authors: Hulleman R. 
Published: May 2013

An often used method for application validation is the “black box” approach. The functionality or application is tested against predefined protocols and the results are compared to also predefined expected results. The underlying infrastructure is automatically validated in combination with the application.Audit Authorities and GMP regulations (Annex 11, GAMP) ask for a Qualified Infrastructure nowadays.An IT infrastructure is a complex system of IT components working together to enable the user to “use the applications” that run on it.To qualify an infrastructure the infrastructure has to be split up in parts; the “infrastructure components”. The process of building and changing these components has to follow strict Quality requirements.
Transformation of evidence to knowledge: a neglected task within the medical profession
Authors: Steurer J. 
Published: May 2013

A common and far‐reaching fallacy among physicians is to believe that the terms evidence and knowledge mean the same thing. Evidence means the result(s) of research, whereas knowledge stands for “true justifiable belief.” This difference becomes obvious when we take a look at the results from different studies on the same issue. Results of studies on the same issue sometimes vary considerably and make it difficult for the physician to know which results are relevant for the patient sitting or lying in front of him. Two examples for illustration; within the last ten years about 600 studies evaluating the diagnostic accuracy of D‐Dimer in the diagnosis of venous thrombosis have been published and the values for the sensitivity of the test varies between 70% and 98%. Trial results reporting the effect of steroids on survival in patients with septic shock differ between no effect at all and a significant reduction of mortality. Which of these results should physicians trust?As a consequence the transformation of evidence to knowledge, including the handling of varying and partially contradictory results, could and should be one of the main tasks of academic medicine. The transformation of evidence to knowledge makes the results from research applicable to daily practice.An attempt to accomplish this demand is to synthesize the results of various primary studies in systematic reviews with meta‐analyses. The efforts of the Cochrane Collaboration can be mentioned favorably, but some reservations against the assembly line like production of systematic reviews are justified. It is not understandable why primary studies of low methodological quality, rated as such by the reviewers, are still included in systematic reviews. Further, the concern that results from studies with very different patient populations are pooled in systematic reviews pertains.Two approaches to generate medical knowledge that is helpful for physicians will be presented in the lecture for further discussion; the broader utilization of consensus methods, and the derivation of probability functions. Medical knowledge can be defined as “shared experts belief” and consensus methods (Delphi technique and others) are appropriate to specify these beliefs. Beside consensus a valuable result of a carefully performed consensus process is the precise specification where and why disagreement remains. The ideal form of medical knowledge is a comprehensive set of probability functions, for the diagnostic, the prognostic and the etiognostic domain. These probability functions, stored in cyberspace can be used to calculate the probabilities about the presence of an illness, the future course of an illness and the etiology of an illness. Such probability functions can be derived from harvesting experts' knowledge – the quasi scientific method –, or from patient data – the scientific method. The emerging opportunities in computational science and information technology will make the dream – a comprehensive set of probability functions – to become reality.
Cord blood banking in Europe and worldwide: factors of organization and sustainability
Authors: Bart T. 
Published: May 2013

BackgroundIn the public sector, currently almost 600,000 cord blood units (CBU's) in over 150 public cord blood banks (CBB's), and an estimated 1,000,000 CBU's is stored in over 200 private CBB's.Aims & MethodsAn overview on current international state of public and private CB Banking including an outlook on different concepts of hybrid banking (public and private CB Banking combined) is given. Possible factors influencing financial sustainability and economic viability of CB Banks, i.e. cell count TNC, and HLA haplotype distribution) are taken into consideration.ConclusionsBanking CBU's with predominantly high TNC figures is one way to improve the business model of a public CB Bank, with regard to the establishment of financially sustainable operations. Current recruitment practices of storing low TNC count CBU's with rare HLA haplotypes for the sake of HLA diversity should be carefully scrutinized in this context.
Anthony Nolan: experiences with recruiting 16‐ and 17‐year olds as blood stem cell donors
Authors: O'Leary A. 
Published: May 2013

AbstractBackgroundOn 1 October 2012 Anthony Nolan launched a new donor recruitment policy allowing only those aged 16–30 to join the registry.AimsThe anticipated benefits were: (1) Providing more potentially life‐saving transplants from younger donors. (2) Gradually lowering the average age of the registry, thereby providing more opportunities for potential donors to come up as a match. (3) Focusing our valuable resources on recruiting those who are most likely to be selected to donate.MethodsTo ensure a smooth changeover from the previous joining policy a programme of work took place to: (1) Prepare all documentation. (2) Revisit our donor recruitment strategy. (3) Develop a plan to communicate the change to staff, the public and key stakeholders. (4) Amend existing and prepare new communications and materials. The change was implemented on 1 October 2012 and launched with a national press release, a donor recruitment event at a post‐16 education centre and much activity on social media.ResultsRecruitment events There was concern that the recruitment rate may decrease due to the new joining policy. Though the number of large‐scale patient appeals, we have counteracted this by focusing our efforts on younger donors. Recruitment predictions have been surpassed for this period. Online The impact of the publicity surrounding the policy change was reflected immediately in activity on our website, with more than 1,000 people applying to join the registry in the first week. The weekly average previously was around 350. Social Media Social media played a key role in communicating the policy change to our target audiences. Twitter and Facebook were essential in engaging current supporters to back the change in policy and help to promote it to new audiences. On one day of high volume recruitment in January 2013, 57% of people who applied online stated that they heard about the registry through social media.Summary / ConclusionsWe are committed to engaging with younger audiences in order to recruit younger donors and improve the quality of the registry. Already the average age of those joining the registry has reduced to 21 and we know that recruiting younger donors will help us to offer the best chance of life to patients in need of a transplant.
DEHP plasticizer and blood bags: challenges ahead
Authors: Lozano M. , Cid J. 
Published: May 2013

The invention of the plastic container represented a major advance in haemotherapy that opened the door to blood component preparation and transfusion. Later, it was found that the plasticizer di‐2‐ethylhexyl‐phthalate (DEHP) used in combination with polyvinylchloride (PVC), leached to the blood component contained in the plastic bag and that in the case of the red blood cells, stabilized the membrane allowing the extension of storage up to 49 days, depending on the additive solution used. This extraction of the plasticizer to the components provokes that not only the recipients of transfusions are exposed to significant levels of DEHP but also plasma and platelet apheresis donors are exposed. Although clear‐cut human toxicity has not been identified, for some the precautionary principle should be evoked and in front of the current available data, particularly in neonates and children, only DEHP‐free disposable should be used in bags containing blood components for transfusion. For platelets this has already been accomplished for most of the containers and for plasma it should not be a problem to attain it. However, for the most often transfused blood component, red blood cells concentrates, continues to be an unresolved challenge, although in recent years some new plasticizers appear to be promising safer alternatives.
Stem cell originated red blood cell cultures: status quo and outlook
Authors: Mazurier C. , Douay L. 
Published: May 2013

The present paper reports the various obstacles cleared during the past decade with the view of generating red blood cells in vitro from various sources of stem cells, for transfusion purposes. We also consider the next developments to be performed for achieving this goal. Starting from the natural source, the haematopoietic stem cells, the major advance resides in the establishment of the proof of principle for transfusion in human, by showing a normal life span of cultured Red blood cells compared to their native counterpart. The best available source of highly proliferative adult stem cells is cord blood, with the capacity of generating the equivalent of 100 units of packed RBC from one average unit. It is, however, a limited source in terms of haematopoietic stem cells and remains dependent on donations as observed from conventional blood supply. Critical advances have allowed the in vitro production of functional RBC from pluripotent human stem cells, embryonic and induced pluripotent stem cells, in the past 5 years. Because induced pluripotent stem cells (iPS) can proliferate indefinitely and be selected for a phenotype of interest, they appear the most favourable source of stem cells. Proof of concept of the generation of RBC from iPS has been made, but still needs to be optimized. We also discuss the key points that remain to be resolved to achieve an application for clinical transfusion. Several crucial points remain to be resolved notably to ensure the safety of iPS of clinical grade, the optimization of the erythrocyte differentiation and cellular amplification, and finally, the definition of GMP conditions for industrial production.
Clinical trials on platelet transfusion: successes and failures
Authors: Heddle N. M. 
Published: May 2013

Platelet transfusions are a commonly used medical therapy to prevent bleeding (prophylactic use), or to treat patients who are actively bleeding (therapeutic use). The most frequent use of prophylactic platelet transfusions occurs in patients with chemotherapy induced thrombocytopenia, although prophylactic platelet transfusions are also used in other thrombocytopenic patient populations prior to a surgical intervention. Therapeutic platelet transfusions used by many different patient populations with acute hemorrhage including: medical and surgical patients; trauma patients, patients with intraventricular hemorrhage and gastrointestinal bleeds. Randomized controlled trials designed to determine the optimal trigger, optimal dose, efficacy of a therapeutic only platelet transfusion strategy, and efficacy of pathogen reduced platelets have contributed to an evidence based approach for platelet transfusions over the past 15 years. Although we have learned a lot from these clinical trials, generalizability is limited with most trials have been conducted in adults with chemotherapy induced thrombocytopenia. There is a paucity of evidence to inform transfusion therapy in other patient populations. Methodological challenges associated with many of these studies have hampered the overall acceptance of the results; hence, knowledge uptake has been slow raising the question: why evidence based platelet transfusion changes occur so slowing even when RCT data are available? The answer to this question is complex but may include: research design limitations; the lack of generalizability of data from hematology/oncology patients to other patient populations; and, methodological limitations including clinical relevance and/or challenges with measuring the outcome.Information generated through clinical research related to platelet transfusion has provided some guidance to inform the practice of evidence based platelet transfusion therapy; however, along that path we have also recognized the flaws and limitations of the clinical research methodology used which has limited practice change. The question for transfusion researchers today is –how do we move forward from here to ensure that research resources are best spent to inform evidence based practices that will benefit our patients? In this presentation what we know about evidence based transfusion practices will be reviewed with emphasis on the potential limitations associated with clinical research as explanations for the lack of practice change. Activities underway to overcome some of these limitations will also be discussed.
Challenges for developing sustainable blood transfusion services in the Caribbean
Authors: Duits A. J. 
Published: May 2013

Blood transfusion services are an essential part of health care. Timely availability of safe blood is a major challenge in developing countries. The Caribbean region faces interesting challenges in achieving a sustainable blood transfusion program. Several key issues need to be addressed in order to achieve a sustainable program. The use of replacement donors is widely spread with achieving complete coverage by non‐remunerated voluntary donors still far away. With support of external agencies several important documents and training efforts have been produced. However it should be mentioned that economies of scale, resources and local culture still provide major challenges for achieving the goals set by the different countries in the region as mentioned in their regional plan of action.Interestingly these efforts have also provided a unique compilation of relevant data for the Caribbean region. These data provide information on the situation in all the countries regarding essential/key areas needed to be addressed like national programs, self sufficiency, regulations and legislation, quality systems and human resources. Special attention is given to development of a reliable hemovigilance system.Further governmental commitment, improvement of horizontal collaboration and continued support by external agencies like the PAHO, WHO and AABB is necessary to achieve sustainability of quality blood transfusion services.
Molecular DNA‐based testing for blood group antigens: recipient–donor focus
Authors: Westhoff C. M. 
Published: May 2013

DNA‐based testing for blood group antigens has become commonplace in a number of clinical situations to improve transfusion therapy for blood transfusion recipients. These include typing for antigens in patients who are multiply transfused to determine which blood group antibodies may be present, typing when the red blood cells (RBCs) are coated with immunoglobulin, and typing for uncommon antigens, especially when no serologic reagent is available. Other clinical applications include resolving ABO typing discrepancies for patients awaiting transplant, or determination of the original type of a bone marrow transplant recipient, or confirmation of an ABO subgroup in a kidney donor. Testing for the specific mutation associated with depressed Kell system antigens in McLeod syndrome may also have value because different mutations appear to be associated with prognosis.Applications in prenatal medicine include discrimination between weak D and partial D to determine if a pregnant woman is a candidate for Rh immune prophylaxis, and assessing the risk for hemolytic disease of the fetus or newborn and neonatal thrombocytopenia. Assessing risk includes testing the paternal sample for the target antigen, and if positive testing for gene copy number (zygosity) and testing the fetus from amniocentesis or non‐invasive maternal plasma sample.Donor centers are now able to screen large numbers of donors to label antigen‐negative RBC products. DNA typing will change transfusion practice by allowing patients facing chronic transfusion therapy to have a more comprehensive blood group antigen profile performed, and to receive donor units antigen‐matched for more than ABO and RhD to reduce alloimmunization. A patient who makes an alloantibody to a RBC antigen is forever at risk for his or her lifetime; for a serious transfusion reaction if ever requiring transfusion in an emergency, and also for a high risk pregnancy if a woman of child bearing age. Prevention of alloimmunization is an important advance in transfusion safety and is now possible with electronic patient medical records and testing and labeling of blood products for additional blood group antigens.
The cellular pathophysiology of immune thrombocytopenia
Authors: Semple J. W. 
Published: May 2013

BackgroundImmune thrombocytopenia (ITP) is a bleeding disorder with circulating platelet counts of <100 9 109/l, in the absence of any other resultant cause or disorder. This disease is primarily mediated by two major immune mechanisms. The predominant response occurs when immunoglobulin G (IgG) autoantibodies are produced against platelet self‐antigens resulting in platelet opsonization and increased Fc‐receptor‐mediated phagocytosis and destruction by macrophages within the spleen. In addition, these IgG autoantibodies can also mediate megakaryocyte inhibition/destruction within the bone marrow. The second immune response concerns T‐cell‐mediated platelet destruction in the periphery and megakaryocyte destruction/inhibition in the bone marrow. One or both of these mechanisms of immune mediated thrombocytopenia may lead to reduced levels of platelets.ResultsIt appears that ITP is associated with many varied defects at the level of antigen presenting cells, T cells and B cells. The primary defect in active disease appears to be an expansion of pro‐inflammatory Th17 cells with a concomitant deficiency in T and B regulatory cells.ConclusionThis article will summarize the role of cellular autoreactive mechanisms associated with ITP to gain a greater understanding of the pathophysiology of this autoimmune bleeding disorder.