{"title":"FDA guidance on bacterial contamination risk control strategies to enhance the safety and availability of platelets: advantages and limitations","authors":"M. R. Jacobs","doi":"10.21037/AOB-21-10","DOIUrl":"https://doi.org/10.21037/AOB-21-10","url":null,"abstract":"Bacterial contamination of platelets was first addressed by primary culture, introduced in US in 2004, which ameliorated but did not solve the problem. Guidance to further decrease bacterial contamination were published by the US Food and Drug Administration in September 2019; recommended implementation is by October 2021. These include three single-step strategies: (I) culture at ≥36 h of ≥16 mL (≥8 mL aerobic, ≥8 mL anaerobic) per split apheresis unit or whole-blood derived pool; 5 day outdate; (II) culture at ≥48 h of ≥16 mL (≥8 mL aerobic, ≥8 mL anaerobic) per split apheresis unit; 7 day outdate; (III) pathogen reduction of apheresis units performed within 24 h of collection (5-day outdate). Several two-step strategies are available: First step has two options: (I) culture ≥36 h of ≥16 mL as in single-step option 1 (5 day outdate); (II) culture at ≥24 h after collection of ≥16 mL (≥8 mL aerobic, ≥8 mL anaerobic) per apheresis collection or split unit, or whole-blood derived pool (3 day outdate). The second step has three options to extend these outdates: (I) secondary culture of each unit of ≥8 mL (aerobic) on ≥ day 3 (extends outdate to 5 days); (II) secondary culture of each unit of ≥16 mL as in step 1 on ≥ day 4 (extends outdate to 7 days); (III) rapid testing of each unit within 24 hours of transfusion on ≥ day 3 (extends outdate to 7 days). This review addresses advantages and limitations of these strategies based on evidence of their efficacy.","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44027346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Management of immune thrombocytopenia in pregnancy","authors":"Jacqueline N. Poston, T. Gernsheimer","doi":"10.21037/AOB-20-58","DOIUrl":"https://doi.org/10.21037/AOB-20-58","url":null,"abstract":"Immune thrombocytopenia (ITP) presents unique challenges in the peripartum setting. The diagnosis of ITP is similar to the nonpregnant patient except pregnancy related causes of thrombocytopenia must be considered. Management of ITP will change over the course of pregnancy and closer monitoring is critical as delivery approaches when the recommended platelet goal increases from 20×10–30×10/L to above 50×10/L for a vaginal delivery. If an epidural is required, the platelet count should be above 70×10/L. The mode of delivery is based on obstetrical indications. First line therapies are glucocorticoids or intravenous immunoglobulin (IVIG). Many second line therapies may be safe in pregnancy. Contraindicated therapies include syk inhibitors, vinca alkaloids, mycophenolate mofetil, cyclophosphamide and danazol. Limited case series report safe administration of the thrombopoietin receptor agonists (TPORAs) without adverse fetal outcomes. While the majority of neonates are unaffected, neonatal platelet counts can decline in the first days after delivery and may require therapy. Maternal treatment and platelet count do not appear to predict the risk of neonatal thrombocytopenia; the strongest predictor is a previous sibling’s history. ITP is not a contraindication for pregnancy; women with a history of ITP should not be discouraged from becoming pregnant as their ITP can be safely managed with close monitoring and multidisciplinary coordination with obstetrics and pediatrics.","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48396776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of bloodPub Date : 2021-03-01DOI: 10.21037/AOB-2021-01
J. Semple, R. Kapur
{"title":"Focused themed issue on immune thrombocytopenia (ITP)","authors":"J. Semple, R. Kapur","doi":"10.21037/AOB-2021-01","DOIUrl":"https://doi.org/10.21037/AOB-2021-01","url":null,"abstract":"Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder mediated by anti-platelet autoantibodies and antigen-specific T cells (1,2). These immune effectors either destroy platelets peripherally in the spleen and/or impair platelet production in the bone marrow. The most recent pathophysiologic studies have shown that abnormal T cell responses, particularly, defective T regulatory cell (Treg) activity are central to the autoimmune pathogenesis of ITP and various therapeutics can restore these responses. Just in the last 2 years, for example, there is a significant literature on ITP pathophysiology and it points to the concept that the disease is initiated by flawed self-tolerance mechanisms (1). It appears that understanding how to specifically modulate T cells in patients with ITP will undoubtedly lead to effective antigen-specific therapeutics. This issue of AOB will be dedicated to ITP with a series of manuscripts written by leading experts in the field of ITP management and treatment. It now appears that a great deal of new treatments are available for the disease, and we now have a better understanding of how these new treatments may increase platelet counts in ITP. In the first chapter, Branch (3) and colleagues re-visit what is known about the efficacy and mechanism of action of intravenous immunoglobulin (IVIg) treatment for ITP in adults. IVIg has been used for almost 40 years as a therapeutic for the treatment of ITP and was originally found to be an efficacious treatment for pediatric ITP and later for adults suffering from the disorder. The chapter delves into the success of IVIg treatment over the years and highlights its use with other therapeutics. It points out that despite its many years of use, the mechanism of action of IVIg in ITP still remains controversial with many experimentally-supported theories as to its mechanism of action. Even so, the authors suggest that IVIg will likely continue to be a first-line therapy for adult ITP, particularly when patients suffer from bleeding symptoms. In the second chapter Schmidt (4) and colleagues discuss IVIg usage in pediatric patients with ITP. In childhood ITP, morbidity is significant due to the risk of bleeding and there is a reduced health-related quality of life (HRQoL). The authors suggest that IVIg treatment accelerates the remission of thrombocytopenia in newly diagnosed ITP and reduces bleeding symptoms, but there are disadvantages such as side effects and costs. They discuss their recent randomized controlled study (TIKI) that showed that IVIg does not affect the development of chronic ITP. It appears that approximately 60% of children with newly diagnosed ITP have a sustained response to IVIg and this response is associated with long-term remission. They then move into recent molecular and clinical data, which shows that treatment responders can be identified before IVIg administration and this is associated with a transient, self-limiting ITP disease course. They c","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46962114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D. Schmidt, K. M. Heitink-Polle, M. Bruin, M. Haas
{"title":"Intravenous immunoglobulins (IVIg) in childhood immune thrombocytopenia: towards personalized medicine—a narrative review","authors":"D. Schmidt, K. M. Heitink-Polle, M. Bruin, M. Haas","doi":"10.21037/AOB-20-59","DOIUrl":"https://doi.org/10.21037/AOB-20-59","url":null,"abstract":": In childhood immune thrombocytopenia (ITP), the morbidity is significant due to the risk of bleeding and a reduced health-related quality of life (HRQoL). Current management guidelines indicate that treatment is considered for children with moderate to severe bleeding, or a reduced HRQoL. Intravenous immunoglobulin (IVIg) treatment has been introduced in childhood ITP in 1981. IVIg treatment speeds up the remission of thrombocytopenia in newly diagnosed ITP and reduces bleeding symptoms, but this has the disadvantage of side effects and costs. Some data indicated that IVIg may modulate the late disease outcomes of ITP, but our recent randomized controlled trial (RCT) showed that IVIg does not affect the development of chronic ITP. Overall, 60% of children with newly diagnosed ITP show a sustained response to IVIg. Such a sustained response after IVIg treatment is strongly associated with long-term remission from ITP. Recent molecular and clinical data show that treatment responders could be identified before IVIg is administered. The same molecular and clinical characteristics that identify treatment responders are otherwise associated with a transient, self-limiting ITP disease course, suggesting the identification of a distinct subgroup of ITP patients. Thus, the development of multivariate clinical and molecular prediction scores could allow to individualize treatment decisions, i.e., target IVIg to those who benefit the most. These prediction scores may also be used to design studies aimed at identifying children who benefit from adjunctive or alternative treatments, such as thrombopoietin receptor agonists (TPO-Ra).","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48750813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Immune thrombocytopenia: the patient’s perspective","authors":"C. Kruse, A. Kruse, J. DiRaimo","doi":"10.21037/aob-20-57","DOIUrl":"https://doi.org/10.21037/aob-20-57","url":null,"abstract":": Immune thrombocytopenia (ITP) is a rare heterogeneous autoimmune bleeding disorder that causes a lower than normal circulating platelet count resulting from impaired platelet production and accelerated platelet destruction. Patients with ITP face a complex set of challenges. The multifaceted burden of living with ITP impacts the overall health-related quality of life (HRQoL) of patients and their families. Here, we review the patients’ perspective on unmet needs, and the physical and emotional burden of disease in an attempt to highlight areas where healthcare providers treating ITP can enhance their current approach to managing a patient with this rare disease. Patients want their voices heard and their experiences with ITP acknowledged beyond simply treating the platelet count. Unmet needs identified include knowledge and communication deficiencies, the need for diagnostic improvements, access issues to the most appropriate treatments, and awareness of the extent to which ITP impacts HRQoL both on physical and mental health. ITP leads to fatigue, challenges with daily activities, reduced physical functioning, anxiety, and depression. Aside from the constant risk for serious bleeding, patients experience both physical and emotional consequences living with their disease on a daily basis. Further studies are needed to clarify the nature and source of pain, anxiety, depression, and fatigue reported in both adults and pediatric patients living with ITP. 13","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48985556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of bloodPub Date : 2021-01-20DOI: 10.21037/AOB-2020-CP-02
G. Grisolia, Alessia Pinto, Giorgia Pavan, M. Capuzzo, M. Franchini
{"title":"COVID-19 and pregnancy: a narrative review on the use of convalescent plasma","authors":"G. Grisolia, Alessia Pinto, Giorgia Pavan, M. Capuzzo, M. Franchini","doi":"10.21037/AOB-2020-CP-02","DOIUrl":"https://doi.org/10.21037/AOB-2020-CP-02","url":null,"abstract":"The emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is a global concern, considering both the severity of the disease, with a high mortality rate compared to that of other influenza-like viral illnesses, and the lack of a specific, effective treatment. Pregnant women with coronavirus disease 2019 (COVID-19) represent a further challenge for clinicians. Indeed, although the majority of them are asymptomatic or their SARS-CoV-2 disease has a mild to moderate course, in some cases this viral infection is accompanied by severe respiratory symptoms. In such a critical clinical setting, the already limited therapeutic armamentarium available for COVID-19 patients is further restricted in pregnant women because of the risk of fetal toxicity especially during the first trimester of gestation. Among the treatment options, the use of convalescent plasma has gained increasing interest from investigators in pregnant women, given the initial positive reports on safety and efficacy aspects of this treatment in critically ill COVID-19 patients. However, the literature data are scanty and almost limited to single case reports, considering that pregnant women are usually excluded from trials on convalescent plasma. In this narrative review, we will critically discuss the current literature evidence on the use of hyperimmune plasma during pregnancies complicated by COVID-19.","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45284307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of bloodPub Date : 2021-01-18DOI: 10.21037/AOB-2020-PT-03
T. Jimenez‐Marco
{"title":"Pathogen reduction of platelets: experience of a single blood bank","authors":"T. Jimenez‐Marco","doi":"10.21037/AOB-2020-PT-03","DOIUrl":"https://doi.org/10.21037/AOB-2020-PT-03","url":null,"abstract":": Pathogen reduction technology (PRT) has the potential to prevent pathogen transfusion transmission from blood donor to patient by impeding the replication of bacteria, viruses and parasites in blood components. Additionally, PRT can help to guarantee blood safety in challenging situations for blood supply, as in the Ebola or Chikungunya epidemics, or in a scenario full of uncertainties such as the current SARS-CoV-2 pandemic. The Balearic Islands Blood Bank (BIBB) is one of the few blood establishments worldwide with more than 10 years of experience in the routine use of amotosalen/UVA (Intercept Blood System) and riboflavin/UVA-UVB (Mirasol PRT system) for platelets (PLTs), the use of riboflavin/UVA-UVB for plasma and with research experience in riboflavin/UVA-UVB applied to whole blood. Over the years, we have had the opportunity to evaluate PRT from different perspectives, such as clinical and hemovigilance research in adults and children, in vitro studies on PRT effects on PLTs and assessing the financial impact of PRT implementation. PRT methods offer remarkable benefits but also have certain limitations, which are important to bear in mind during the decision-making process for PRT implementation. The purpose of this study is to review the current knowledge on PRT for PLTs drawing on our experience acquired over the last decade.","PeriodicalId":72211,"journal":{"name":"Annals of blood","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44121000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}