33 research outputs found

    Stepwise access to safe plasma proteins in resource‐constrained countries:Local production and pathways to fractionation—Report of an International Society of Blood Transfusion Workshop

    Get PDF
    Background and Objectives Actions are needed to improve access to safe plasma-derived medicinal products (PDMPs) in low- and middle-income countries (LMICs). Materials and Methods The International Society of Blood Transfusion (ISBT) Working Party for Global Blood Safety organized an on-line workshop during 21–23 September 2021 to advance access to safe plasma proteins in resource-constrained countries, consistent with recent World Health Organization (WHO) guidance documents. Results The meeting drew attention to the considerable unmet needs for access to essential PDMPs in LMICs, in particular coagulation factors and immunoglobulins, and stepwise actions to address these deficits. First, improved access to safe plasma protein therapies requires blood component separation with prevention of wastage of recovered plasma. Quality and safety of collected blood and plasma must be assured so that plasma in excess of transfusion needs can be processed into safe plasma proteins. Second, local production of safe plasma proteins can be implemented using available technologies to locally obtain pathogen-reduced plasma and prepare pathogen-reduced cryoprecipitate and immunoglobulins from small plasma pools. Third, when a sufficient, stable volume of quality-assured plasma is available (approximately 50,000 L/year), contract or toll fractionation by a foreign plasma fractionator can expand the supply of PDMPs. Fourth, when the national infrastructure supports high-technology industrial production and stable volumes of quality plasma reach at least 200,000 L/year, technology transfer for domestic fractionation can be considered. Conclusion Action is needed including commitments of the organizations that made the workshop possible (WHO, ISBT, World Federation of Haemophilia [WFH], Plasma Protein Therapeutics Association [PPTA], International Plasma Fractionation Association [IPFA], International Patient Organization of Primary Immunodeficiencies [IPOPI] and International Federation of Blood Donor Organizations [FIODS])

    The evolving role of information technology in haemovigilance systems

    Get PDF
    This work provides an overview and appraisal of the general evolution of IS/IT in haemovigilance, from which lessons can be learned for its future strategic management. An electronic survey was conducted among the members of the International Haemovigilance Network to compile information on the mechanisms implemented to gather, process, validate, and store these data, to monitor haemovigilance activity, and to produce analytical reports. Survey responses were analysed by means of descriptive statistics, and comments/observations were considered in the final discussion. The answers received from 23 haemovigilance organizations show a direct relationship between the number of collected notifications (i.e., communication of adverse effects and events) and the technical specifications of the haemovigilance system in use. Notably, IT is used in the notification reception of 17 of these systems, out of which 8 systems are exclusively based on Web solutions. Most assessments of the evolution of IS/IT tend to focus on the scalability and flexibility of data gathering and reporting, considering the ever-changing requirements of haemovigilance. Data validation is poorly implemented, and data reporting has not reached its full potential. Web-based solutions are seen as the most intuitive and flexible for a system-user interaction.This work would not be possible without the precious collaboration of the IHN and the generous participation of the survey respondents. The SING group thanks CITI (Centro de Investigación, Transferencia e Innovación) from UniversityofVigoforhostingitsITinfrastructure.Thiswork was partially funded by the European Union’s Seventh Framework Programme FP7/REGPOT-2012-2013.1 (Grant Agreement no. 316265, BIOCAPS), the Fundação para a Ciência eaTecnologia (FCT) under thescopeofthestrategic funding of the UID/BIO/04469/2013 unit, and COMPETE 2020 (POCI-01-0145-FEDER-006684).info:eu-repo/semantics/publishedVersio

    Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

    Get PDF
    Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

    Abstracts from the Food Allergy and Anaphylaxis Meeting 2016

    Get PDF

    Decomposition of the complete directed graph into k-circuits

    Get PDF
    International audienc
    corecore