Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks.

Introduction: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

Methods: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

Demographics of first-time donors returning for donation during the pandemic: COVID-19 convalescent plasma versus standard blood product donors.

Background: Previous studies have demonstrated low first-time donor return rates (DRR) following catastrophic events. Little is known, however, about the influence of demographic factors on the DRR of first-time donors during the COVID-19 pandemic, including the unique motivation of COVID-19 convalescent plasma (CCP) donors as compared to non-CCP donors.

Study Design And Methods: Thirteen blood collection organizations submitted deidentified data from first-time CCP and non-CCP donors returning for regular (non-CCP) donations during the pandemic.

How do I initiate and maintain a mobile apheresis service in the era of cellular therapy.

Background: Mobile delivery of apheresis services is an increasingly important component of health care equity, as patients should not have to transfer care providers or travel far distances to receive critical therapeutic apheresis procedures or cell therapy-based treatments. Therefore, the availability of such services should be expanded.

Study Design And Methods: In this "How Do I" article, we provide a detailed overview of the elements necessary to initiate and maintain a successful mobile apheresis service, including challenges and potential solutions.

Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.

Background: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma.

Transfusion practices for pediatric oncology and hematopoietic stem cell transplantation patients: Data from the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III).

Background: To evaluate transfusion practices in pediatric oncology and hematopoietic stem cell transplant (HSCT) patients.

Study Design And Methods: This is a multicenter retrospective study of children with oncologic diagnoses treated from 2013 to 2016 at hospitals participating in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III. Transfusion practices were evaluated by diagnosis codes and pre-transfusion laboratory values.

Transfusion Practices in Pediatric Cardiac Surgery Requiring Cardiopulmonary Bypass: A Secondary Analysis of a Clinical Database.

Objectives: To describe blood component usage in transfused children with congenital heart disease undergoing cardiopulmonary bypass surgery across perioperative settings and diagnostic categories.

Design: Datasets from U.S.

Transfusion practices in a large cohort of hospitalized children.

Background: While previous studies have described the use of blood components in subsets of children, such as the critically ill, little is known about transfusion practices in hospitalized children across all departments and diagnostic categories. We sought to describe the utilization of red blood cell, platelet, plasma, and cryoprecipitate transfusions across hospital settings and diagnostic categories in a large cohort of hospitalized children.

Study Design And Methods: The public datasets from 11 US academic and community hospitals that participated in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) were accessed.

Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial.

Background: Convalescent plasma has been used for numerous viral diseases including influenza, severe acute respiratory syndrome, Middle East respiratory syndrome and Ebola virus; however, evidence to support its use is weak. SARS-CoV-2 is a novel coronavirus responsible for the 2019 global pandemic of COVID-19 community acquired pneumonia. We have undertaken a randomized controlled trial to assess the efficacy and safety of COVID-19 convalescent plasma (CCP) in patients with SARS-CoV-2 infection.

Characteristics of coronavirus disease 19 convalescent plasma donors and donations in the New York metropolitan area.

Background: Convalescent plasma (CP) is an important initial treatment in pandemics and the New York (NY) metropolitan area is likely to remain a hotspot for collection and distribution of such units. This study reports characteristics of coronavirus disease 19 CP (CCP) donors and their donations to the New York Blood Center (NYBC).

Study Design And Methods: All CCP data from our first day of collection on March 26th through July 7th, 2020 are included in this retrospective analysis.

Variation in Neonatal Transfusion Practice.

Objective: To estimate the incidence of blood product transfusion, including red blood cells, platelets, and plasma, and characterize pretransfusion hematologic values for infants during their initial hospitalization after birth.

Study Design: Retrospective cohort study using data from 7 geographically diverse US academic and community hospitals that participated in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) from 2013 to 2016. Pretransfusion hematologic values were evaluated closest to each transfusion and no more than 24 hours beforehand.

Potentially modifiable predictors of cell collection efficiencies and product characteristics of allogeneic hematopoietic progenitor cell collections.

Background: Hematopoietic progenitor cell (HPC) and immune effector cell (IEC) therapies often require high doses of mononuclear cells (MNCs), whether CD34+ cells, lymphocytes, or monocytes. Cells for IEC can be sourced from HPC products. We thus examined potentially modifiable variables affecting collection efficiencies (CEs) of MNC subsets in HPC collection and also of the typically undesired cell types of platelets, granulocytes, and red cells, which hinder downstream processing.

Safety and benefits of automated red cell depletion-exchange compared to standard exchange in patients with sickle cell disease undergoing chronic transfusion.

Background: The Spectra Optia allows automated performance of red blood cell reduction and isovolemic hemodilution (IHD) prior to standard red cell exchange (RCE), and is primarily intended for patients with sickle cell disease (SCD) undergoing chronic RCE. Data on the safety of inducing transient further anemia and the benefits of IHD-RCE is limited and occasionally contradictory.

Study Design And Methods: In this retrospective crossover analysis of six patients with SCD who underwent chronic exchange with standard RCE (Cobe Spectra) followed by IHD-RCE (Spectra Optia), we compared safety and benefit outcomes with IHD-RCE vs standard RCE.

How did we rapidly implement a convalescent plasma program?

Since the beginning of the COVID-19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S.

Additive effects of blood donor smoking and gamma irradiation on outcome measures of red blood cell transfusion.

Background: Recent publications have reported conflicting results regarding the role of blood donor tobacco use on hemoglobin (Hb) levels in patients after red blood cell (RBC) transfusion. We examined associations and interactions between donor, component, and recipient factors to better understand the impact of donor smoking on transfusion outcomes.

Study Design And Methods: We linked blood donor and component manufacturing data, including self-reported cigarette smoking, with a cohort of patients transfused RBCs between 2013 and 2016.

Deployment of convalescent plasma for the prevention and treatment of COVID-19.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis. To date, there are no proven options for prophylaxis for those who have been exposed to SARS-CoV-2, nor therapy for those who develop COVID-19. Immune (i.

Validation of simple prediction algorithms to consistently achieve CD3+ and postselection CD34+ targets with leukapheresis.

Background: Cellular therapies using engineered T cells, haploidentical transplants, and autologous gene therapy are increasing. Specified CD3+ or high CD34+ doses are typically required for subsequent manufacturing, manipulation, or CD34+ selection. Simple, practical, and reliable lymphocyte and hematopoietic progenitor cell (HPC) collection algorithms accounting for subsequent CD34+ selection have not been published.

Red blood cells donated by smokers: A pilot investigation of recipient transfusion outcomes.

Background: Current regulations do not require blood collection facilities to ask donors about cigarette smoking, and the prevalence of nicotine and its metabolites in blood products is not well established. Although smokers have higher hemoglobin (Hb) levels, smoking may adversely affect the quality of donated red blood cells through higher carboxyhemoglobin (COHb) content and premature hemolysis.

Study Design And Methods: Red blood cell (RBC) unit segments from 100 unique donors were tested for nicotine and its metabolite cotinine by mass spectrometry and for COHb spectrophotometrically.

A dual strategy to optimize hematopoietic progenitor cell collections: validation of a simple prediction algorithm and use of collect flow rates guided by mononuclear cell count.

Background: Previous prediction algorithms to achieve target CD34+ goals have not been widely adopted, with many centers still using a set volume to process for hematopoietic progenitor cell collections. This may be because previous algorithms are challenging to implement. Additionally, no study has yet examined the utility of adjusting the collect flow rate (CFR) based on the donor's preprocedure total mononuclear cell (MNC) count, which correlates with CD34+ yield.

Apheresis to Mitigate Atherosclerotic Vascular Disease.

Background: Therapeutic apheresis is a term used to describe a group of treatments where blood components are separated in real time, and one component is removed, exchanged, and/or treated to remove pathogenic substances from the circulation. Plasma exchange, which removed all plasma components, and lipid apheresis which selectively removes lipoproteins from circulation, have both been used to treat atherosclerotic vascular diseases.

Methods: To review the literature regarding the application of therapeutic apheresis for atherosclerotic vascular diseases.

Clinical outcomes in a cohort of patients with heparin-induced thrombocytopenia.

Background: Heparin-induced thrombocytopenia (HIT) is a thrombotic disorder usually prompting treatment with non-heparin anticoagulants. The benefits and risks of such treatments have not been fully assessed.

Methods: We analyzed data for 442 patients having a positive heparin-platelet factor 4 antibody test and recent heparin exposure.