Search

In March 2020, there were no treatment options for COVID-19. Passive immune therapy including anti-SARS-CoV-2 hyperimmune globulin (hIVIG) was a logical candidate for COVID-19 therapeutic trials, given past success treating emerging pathogens with endogenous neutralizing antibodies. We established a plasma collection protocol for persons recovered from COVID-19. To speed recruitment in the first U.S. hotspot, Seattle, Washington, federal and state public health agencies collaborated with Bloodworks Northwest to collect convalescent plasma (CP) for manufacturing hIVIG. During March–December 2020, we identified and recruited prospective CP donors via letters to persons recovered from COVID-19 with laboratory-confirmed SARS-CoV-2 infection. Prospective donors were pre-screened and administered a medical history survey. Anti-SARS-CoV-2 neutralizing antibody (NAb) titers were classified as qualifying (≥1:80) or non-qualifying (

Background Platelet inventory constraints can result in minor ABO incompatibility and possible hemolysis. The aims of this study were to determine the reduction of isoagglutinin in titers of platelets stored in additive solution (PAS) and compare its safety, efficiency, and cost-effectiveness with full-volume and plasma-reduced platelets. Study design and methods Isoagglutinin titers were performed in paired whole blood donor samples and apheresis platelets collected in PAS (PAS-PLT) aliquot samples by the tube method. Results A total of 149 pairs of donor/platelet samples were tested: 75 group O, 59 group A, and 15 group B. For group O donor samples, the median anti-A IgG and IgM were 64 and 16, respectively, and the median anti-B IgG and IgM were 64 and 16, respectively. For group O PAS-PLT samples the mean anti-A IgG and IgM, and anti-B IgG and IgM were 32 and 8, and 16 and 8, respectively. For group A donor samples, the mean anti-B IgG and IgM was 8 in both cases; and both titers decreased to 2 in PAS-PLT. For group B donor samples, mean anti-A IgG and IgM was 16 in both cases; and both titers decreased to 4 in PAS-PLT. PAS-PLT demonstrated a net reduction in cost and improved efficiency when compared to plasma reduction. The use of PAS-PLT resulted in a 40% reduction of allergic transfusion reactions. Conclusion The use of PAS decreases plasma isoagglutinin titers, transfusion reactions, and is cost-effective when compared to routine plasma reduction as a strategy to mitigate hemolysis risk from minor incompatible platelet transfusion.

Platelet inventory constraints can result in minor ABO incompatibility and possible hemolysis. The aims of this study were to determine the reduction of isoagglutinin in titers of platelets stored in additive solution (PAS) and compare its safety, efficiency, and cost-effectiveness with full-volume and plasma-reduced platelets.Isoagglutinin titers were performed in paired whole blood donor samples and apheresis platelets collected in PAS (PAS-PLT) aliquot samples by the tube method.A total of 149 pairs of donor/platelet samples were tested: 75 group O, 59 group A, and 15 group B. For group O donor samples, the median anti-A IgG and IgM were 64 and 16, respectively, and the median anti-B IgG and IgM were 64 and 16, respectively. For group O PAS-PLT samples the mean anti-A IgG and IgM, and anti-B IgG and IgM were 32 and 8, and 16 and 8, respectively. For group A donor samples, the mean anti-B IgG and IgM was 8 in both cases; and both titers decreased to 2 in PAS-PLT. For group B donor samples, mean anti-A IgG and IgM was 16 in both cases; and both titers decreased to 4 in PAS-PLT. PAS-PLT demonstrated a net reduction in cost and improved efficiency when compared to plasma reduction. The use of PAS-PLT resulted in a 40% reduction of allergic transfusion reactions.The use of PAS decreases plasma isoagglutinin titers, transfusion reactions, and is cost-effective when compared to routine plasma reduction as a strategy to mitigate hemolysis risk from minor incompatible platelet transfusion.

BACKGROUND: Cryopreservation of hematopoietic progenitor cells using liquid nitrogen and controlled-rate freezing requires complex equipment and highly trained staff and is expensive. We compared the liquid nitrogen method with methods using a combination of dimethyl sulfoxide (DMSO) and hydroxyethyl starch (HES) for cryopreservation followed by storage in mechanical freezers. STUDY DESIGN AND METHODS: Peripheral blood stem cells (PBSCs) were collected from normal donors by apheresis and allocated to one of four preservation and storage conditions: 1) 10% DMSO with freezing in liquid nitrogen and storage in liquid nitrogen, 2) 5% DMSO and 6% HES with freezing and storage in a −80°C mechanical freezer, 3) 5% DMSO and 6% HES with freezing in a −80°C mechanical freezer and storage in a −135°C mechanical freezer, or 4) 5% DMSO and 6% HES with freezing and storage both in a 135°C mechanical freezer. Cells were stored for 5 years during which total nucleated cells (TNCs), cell viability, CD34+ cell content, and colony-forming unit–granulocyte-macrophage content were determined. RESULTS: There were some significant differences in the variables measured during freezing and the 5 years of storage compared to the values before freezing and storage; however, these differences were not consistent and do not favor one protocol over the others. Samples stored for 24 hours before cryopreservation showed a significant decrease in TNCs, but no other significant changes during the 5 years. CONCLUSION: In vitro measurements indicate that PBSCs can be successfully frozen and stored using a combination of DMSO and HES providing smaller amounts of DMSO and allowing simplified freezing and storage conditions.

BACKGROUND: Bacterial contamination of blood components can result in transfusion-transmitted infection, but the risk is not established. STUDY DESIGN AND METHODS: Suspected cases of transfusion-transmitted bacteremia were reported to the CDC by participating blood collection facilities and transfusion services affiliated with the American Red Cross, AABB, or Department of Defense blood programs from 1998 through 2000. A case was defined as any transfusion reaction meeting clinical criteria in which the same organism species was cultured from a blood component and from recipient blood, with the organism pair confirmed as identical by molecular typing. RESULTS: There were 34 cases and 9 deaths. The rate of transfusion-transmitted bacteremia (in events/million units) was 9.98 for single-donor platelets, 10.64 for pooled platelets, and 0.21 for RBC units; for fatal reactions, the rates were 1.94, 2.22, and 0.13, respectively. Patients at greatest risk for death received components containing gram-negative organisms (OR, 7.5; 95% CI, 1.3-64.2; p = 0.009). CONCLUSION: Bacterial contamination of blood is an important cause of transfusion-transmitted infection; infection risk from platelet transfusion is higher compared with that from RBCs, and, overall, the risk of infection from bacterial contamination now may exceed that from viral agents. Recipients of components containing gram-negative organisms are at highest risk for transfusion-related death. The results of this study may help direct efforts to improve transfusion-related patient safety.

BACKGROUND: The transfusion of blood components contaminated with bacteria may have serious clinical consequences, but few data are available on the incidence of these events. A national effort to assess the frequency of blood component bacterial contamination associated with transfusion reaction (the BaCon Study) was initiated to better estimate their occurrence. STUDY DESIGN AND METHODS: Standard reporting criteria, data collection forms, and a standardized reporting protocol were developed in collaboration with the American Red Cross, AABB, and the Department of Defense. Episodes reported to the BaCon Study were compared with those reported to the FDA's national reporting systems to estimate the extent to which all serious reactions associated with bacterial contamination were captured. RESULTS: During the first 2 years, 38 episodes meeting study criteria were reported; 21 were laboratory-confirmed. The estimated proportion of episodes reported to the BaCon Study (i.e., completeness of coverage) was lower than that reported to the FDA during the same period (0.33 vs. 0.68), but the positive predictive value was higher (0.66 vs.0.28). CONCLUSION: Despite the complexity of obtaining reports from a large number of United States hospitals and transfusion centers, the feasibility and usefulness of the BaCon Study were shown. This study was the only national study in the United States to monitor adverse clinical events associated with bacterial contamination of blood components. By building on hospital-based reporting of transfusion-related adverse events, the BaCon Study serves as a model for the study of other complications associated with blood and blood components.

BACKGROUND Recent evidence demonstrates an association between duration of storage of red blood cells (RBC) and morbidity and mortality after cardiac surgery. We studied the feasibility of two different schemes for categorizing and randomizing age of RBC units transfused in cardiac surgical patients. STUDY DESIGN AND METHODS In Phase 1, 20 subjects were randomly assigned to standard of care (SOC) versus no RBCs with more than 21 days' storage duration. In Phase 2, 23 subjects were randomized to RBCs of 7 +/- 4 versus 21 +/- 4 days' storage duration. The age of study RBC units was masked. RESULTS In Phase 1, no patients received RBCs 31 days or older in SOC, and there was overlap in storage age shared in both arms so the predefined feasibility criteria were not met. In Phase 2, it was feasible to deliver specified age RBCs to the 7-day arm (achieved in 100% of subjects), but feasibility was not demonstrated for the 21-day arm (only 50% of subjects transfused with target age RBCs). Significant differences, however, were observed between the 7 +/- 4- and 21 +/- 4-day arms with respect to age of all RBC units (6 +/- 2 vs. 18 +/- 7, p = 0.0002) and maximum age (7 +/- 2 vs. 20 +/- 7, p < 0.0001). CONCLUSION Given the current storage age distribution of available RBC inventory, use of a SOC arm in future studies is unlikely to result in a large exposure to "old" blood. It is feasible to randomize patients to "younger" RBCs (3-11 days) but design strategies are needed to provide "intermediate-aged" or "old" blood as a comparator.

BACKGROUND : The relative nucleated cell count of umbilical cord blood (CB) correlates with improved engraftment and survival. This study compares two collection methods to assess CB content, including cell numbers. STUDY DESIGN AND METHODS : The Massachusetts CB bank used trained obstetricians and midwives to collect CB in utero before the delivery of the placenta. The banks in California, Ohio, Oregon, and Minnesota used trained American Red Cross (ARC) personnel who collected CB ex utero after the delivery of the placenta. All banks processed CB by RBC sedimentation and volume reduction. RESULTS : The volume and total nucleated cell count of collected CB before processing, as well as after processing CFU-GM and CD34+ cells, showed no advantage of either method. In utero collections resulted in more rejections of collected units (due to labeling problems, bacterial contamination, clotting, and delay between collection and processing) than ex utero collections. There were fewer medical exclusions after in utero collection. CONCLUSION : CB can be collected successfully using either the in utero or ex utero methods; both methods produce comparable nucleated cell, MNC, CD34+, and CFU-GM numbers. Bacterial contamination, low volume, clotting, and delay until processing are generally higher with in utero collection.