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Rebulla P.,Blood Transfusion Service | Vaglio S.,Italian National Blood Center | Beccaria F.,Blood Transfusion Service and Hematology 1 San Martino University HospitalGenoa Italy | Carella A.,Blood Transfusion Service and Hematology 1 San Martino University HospitalGenoa Italy | And 15 more authors.
Transfusion | Year: 2017

BACKGROUND: Two noninferiority, randomized, controlled trials were conducted in parallel comparing the safety and efficacy of platelets treated with Intercept or Mirasol pathogen-reduction technologies versus standard platelets. STUDY DESIGN AND METHODS: The primary endpoint was the percentage of hematology patients who developed World Health Organization Grade 2 or greater bleeding. A noninferiority margin of 11% was chosen based on expected Grade 2 or greater bleeding in 20% of controls. The study was closed for financial restrictions before reaching the planned sample size of 828 patients, and an intention-to-treat analysis was conducted on 424 evaluable patients. RESULTS: In the Intercept trial (113 treated vs. 115 control patients), the absolute risk difference in Grade 2 or greater bleeding was 6.1%, with an upper one-sided 97.5% confidence limit of 19.2%. The absolute risk difference in the Mirasol trial (99 treated vs. 97 control patients) was 4.1%, and the upper one-sided 97.5% confidence limit was 18.4%. Neither absolute risk difference was statistically significant. In both trials, posttransfusion platelet count increments were significantly lower in treated versus control patients. Mean blood component use in treated patients versus controls was 54% higher (95% confidence interval, 36%-74%; Intercept) and 34% higher (95% confidence interval, 16%-54%; Mirasol) for platelets and 23% higher (95% confidence interval, 8%-39%; Intercept) and 32% higher (95% confidence interval, 10%-57%; Mirasol) for red blood cells. Unexpected reactions and adverse events were not reported. Mortality did not differ significantly between treated and control patients. CONCLUSION: Although conclusions on noninferiority could not be drawn due to low statistical power, the study provides additional information on the safety and efficacy of pathogen-reduced platelets treated with two commercial pathogen-reduction technologies. © 2017 AABB.

Domanovic D.,European Center for Disease Prevention and ControlStockholm Sweden | Cassini A.,Health Science University | Bekeredjian-Ding I.,Paul Ehrlich InstitutLangen Germany | Bokhorst A.,TRIP FoundationAmsterdam the Netherlands | And 10 more authors.
Transfusion | Year: 2017

BACKGROUND: Bacteria are the pathogens most frequently transmitted through substances of human origin (SoHO). The European Centre for Disease Prevention and Control (ECDC) organized an expert consultation, with the objective of developing a priority list of bacterial pathogens transmissible via SoHO. The list will be used to further assess risks and determine appropriate preventive measures. STUDY DESIGN AND METHODS: The 14 most frequently SoHO-transmitted bacteria identified through a scoping literature review were then prioritized during an expert workshop through a methodology based on multicriteria decision analysis. The selection of the prioritization method was based upon an ECDC framework for best practices in conducting risk-ranking exercises. Three transmission pathways, blood and blood components, tissues and cells, and organs, were considered in the ranking exercise. RESULTS: According to the ranking score (RS), bacteria were organized within each SoHO pathway into one of four risk tiers: Tier 1 (RS ≥ 0.70), Tier 2 (RS = 0.60-0.69), Tier 3 (RS = 0.40-0.59), or Tier 4 (RS < 0.40). The most consistently identified pathogens in the highest risk Tiers 1 and 2 of all three pathways were: Staphylococcus aureus, Klebsiella spp., Escherichia coli, β-hemolytic streptococci, Pseudomonas spp., and Acinetobacter spp. CONCLUSION: Six bacteria were defined as being of the highest priority in respect of the threat to the safety of SoHO and will be the subject of subsequent in-depth risk assessments to be conducted by ECDC to identify measures to mitigate the risk posed by these bacteria. © 2017 AABB.

Calizzani G.,Italian National Blood Center | Vaglio S.,Italian National Blood Center | Arcieri R.,Italian Federation of Haemophilia Societies FedEmo | Menichini I.,Italian Federation of Haemophilia Societies FedEmo | And 10 more authors.
Haemophilia | Year: 2013

The Health Commission of the Conference between the Italian State and Regions recognized the need to establish an institutional accreditation model for Haemophilia Centres (HCs) to be implemented by 21 Regions in order to provide patients with haemophilia and allied inherited coagulations disorders with high and uniform standards of care. The Italian National Blood Centre, on behalf of the Commission, convened a panel of clinicians, patients, experts, representatives from Regions and Ministry of Health. The agreed methodology included: systematic literature review and best practice collection, analysis of provisions and regulations of currently avalable services, priority setting, definition of principles and criteria for the development of recommendations on the optimal requirements for HCs. The result was the formulation of two recommendations sets. Two sets of recommendations were produced. The first concerns regional policy planning, in which the following aspects of comprehensive haemophilia care should be considered for implementation: monitoring and auditing, multidisciplinary approach to clinical care, protocols for emergency management, home treatment and its monitoring, patient registries, drug availability and procurement, recruitment and training of health care professionals. The second set concerns the accreditation process and lists 23 organizational requirements for level 1 HCs and 4 additional requirements for level 2 HCs. These recommendations help to provide Italian Regional Health Authorities with an organizational framework for the provision of comprehensive care to patients with inherited coagulation disorders based on current scientific evidence. © 2013 John Wiley & Sons Ltd.

Rebulla P.,Blood Transfusion Center | Pupella S.,National Institute of Health | Santodirocco M.,Puglia Cord Blood Bank | Greppi N.,Blood Transfusion Center | And 41 more authors.
Blood Transfusion | Year: 2016

Background. In addition to a largely prevalent use for bleeding prophylaxis, platelet concentrates from adult blood have also been used for many years to prepare platelet gels for the repair of topical skin ulcers. Platelet gel can be obtained by activation of fresh, cryopreserved, autologous or allogeneic platelet concentrates with calcium gluconate, thrombin and/or batroxobin. The high content of tissue regenerative factors in cord blood platelets and the widespread availability of allogeneic cord blood units generously donated for haematopoietic transplant but unsuitable for this use solely because of low haematopoietic stem cell content prompted us to develop a national programme to standardise the production of allogeneic cryopreserved cord blood platelet concentrates (CBPC) suitable for later preparation of clinical-grade cord blood platelet gel. Materials and methods. Cord blood units collected at public banks with total nucleated cell counts <1.5×109, platelet count >150×109/L and volume >50 mL, underwent soft centrifugation within 48 hours of collection. Platelet-rich plasma was centrifuged at high speed to obtain a CBPC with target platelet concentration of 800-1,200×109/L, which was cryopreserved, without cryoprotectant, below -40 °C. Results. During 14 months, 13 banks produced 1,080 CBPC with mean (± standard deviation) volume of 11.4±4.4 mL and platelet concentration of 1,003±229×109/L. Total platelet count per CBPC was 11.3±4.9×109. Platelet recovery from cord blood was 47.7±17.8%. About one-third of cord blood units donated for haematopoietic transplant could meet the requirements for preparation of CBPC. The cost of preparation was € 160.92/CBPC. About 2 hours were needed for one technician to prepare four CBPC. Discussion. This study yielded valuable scientific and operational information regarding the development of clinical trials using allogeneic CBPC.

Liumbruno G.M.,San Giovanni Calibita Fatebenefratelli Hospital | Vaglio S.,Immunohematology and Trasfusion Medicine | Grazzini G.,Italian National Blood Center | Spahn D.R.,University of Zürich | Biancofiore G.,Liver Transplant Anesthesia and Critical Care
Minerva Anestesiologica | Year: 2015

The overall use of allogeneic blood transfusions in clinical practice remains relatively high and still varies widely among centres and practitioners. Moreover, allogeneic blood transfusions have historically been linked with risks and complications: some of them (e.g. transfusion reactions and transmission of pathogens) have been largely mitigated through advancements in blood banking whereas some others (e.g. immunomodulation and transfusion-related acute lung injury) appear to have more subtle etiologies and are more difficult to tackle. Furthermore, blood transfusions are costly and the supply of blood is limited. Finally, evidence indicates that a great number of the critically ill patients who are being transfused today may not be having tangible benefits from the transfusion. Patient blood management is an evidence-based, multidisciplinary, multimodal, and patient-tailored approach aimed at reducing or eliminating the need for allogeneic transfusion by managing anaemia, perioperative blood conservation, surgical haemostasis, and blood as well as plasma-derivative drug use. From this point of view, the reduction of allogeneic blood usage is not an end in itself but a tool to achieve better patient clinical outcome. This article focuses on the three-pillar matrix of patient blood management where the understanding of basic physiology and pathophysiology is at the core of evidence-based approaches to optimizing erythropoiesis, minimising bleeding and tolerating anemia. Anesthesiologists and critical care physicians clearly have a key role in patient blood management programmes are and should incorporate its principles into clinical practice-based initiatives that improve patient safety and clinical outcomes. Copyright © 2015 Edizioni Minerva Medica.

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