BACKGROUND: Transfusion of long-stored red blood cells (RBCs) is associated with decreased in vivo RBC recovery, delivery of RBC breakdown products, and increased morbidity and mortality. Reducing the burden of this RBC "storage lesion" is a major challenge in transfusion medicine. Additive solution-7 (AS-7) is a new RBC storage solution designed to improve RBC metabolism by providing phosphate and increasing buff-ering capacity. STUDY DESIGN AND METHODS: Storage quality in AS-7 was measured in a prospective, randomized, three-center trial using units of whole blood from healthy human subjects whose RBCs were stored for up to 56 days in AS-7 (n = 120) or for 42 days in the control solution AS-1 (n = 60). RESULTS: Hemolysis and shedding of protein-containing microvesicles were significantly reduced in RBCs stored in AS-7 for 42 and 56 days compared with RBCs stored in AS-1. Autologous in vivo recoveries of RBCs stored in AS-7 was 88 ± 5% at 42 days (n = 27) and 82 ± 3% at 56 days (n = 27), exceeding recoveries of RBCs stored in currently used solutions. CONCLUSION: Increasing the phosphate, pH range, and buffer capacity of a RBC storage system allowed RBCs to be stored better and longer than currently approved storage systems. AS-7 ameliorates the long-term storage lesion resulting in significantly increased viability in vitro and in vivo. R ed blood cells (RBCs) are the most commonly transfused blood products. 1 However, the occurrence of antigenic blood groups on RBCs means that large numbers of RBC units are required in the inventories of regional blood systems and hospitals to assure that needed types are readily available. 2,3 RBCs for transfusion are prepared either from whole blood collected into CPD or CP2D or from apheresis collection into CP2D or ACD-A. After being processed into components, additional nutrients are provided to the RBCs for long-term storage in the form of an additive solution (AS). 4 RBCs for transfusion may also be leukoreduced before storage. These ASs were developed to provide volume for the dilution of metabolic waste; nutrients, especially adenine; and membrane protectant sugars. The current AS allow RBCs to be stored for up to 42 days with a mean in vivo recovery at the end of storage of 82 ± 7% From the (n = 641), 12% of samples showing less than 75% recovery, and hemolysis of 0.4% (n = 14,087) or 0.5% (n = 344, unpublished). 6 These performance characteristics suggest that ASs are effective and safe, and three ASs are licensed and in use in the United States, AS-1, AS-3, and AS-5, which perform equivalently. 7-9 Additional ASs have been approved for use in other countries including SAG-M, MAP, and PAGGSM for storage for 35 to 42 days. 10-12 The use of 42-day AS-stored RBC products has allowed the development of highly efficient national blood programs with approximately 95% of donated RBCs finding a recipient in Western countries. Recent studies have raised concerns about the safety of stored RBCs associated with the development of a clinically relevant RBC storage lesion, whic...

Given the much higher degree of similarity for rat and human complement compared to mice, this simple rat model is ideal for testing novel inhibitors of classical pathway activation for the prevention and treatment of acute intravascular hemolysis.

BACKGROUND:Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution-7 (AS-7). STUDY DESIGN AND METHODS:We conducted a three-center, three-arm evaluation of a new blood collection system with AS-7 compared to leukoreduced RBCs processed within 8 hours and stored in AS-1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18-24 hr) before component processing and storage at 1 to 6°C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS-7-stored RBCs were evaluated for 51 Cr 24-hour in vivo recovery and long-term survival. RESULTS: Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS-7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS-7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS-7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%). CONCLUSIONS: Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS-7.

BACKGROUND:Overnight, room temperature hold of whole blood (WB) before leukoreduction and component processing offers significant logistic and cost advantages over WB processed within 8 hours. Plasma prepared from WB held at room temperature overnight (PF24RT24WB) may result in a degradation of plasma coagulation protein activities compared to plasma frozen within 8 hours of collection. In this study, we intended to evaluate the bioequivalence (BE) of PF24RT24WB prepared using a new WB collection, leukoreduction, and storage system compared to freshfrozen plasma (FFP) after 12 months of frozen storage. STUDY DESIGN AND METHODS:We conducted a three-center, three-arm evaluation of the LEUKOSEP HWB-600-XL test system (Hemerus Medical LLC) compared to the RZ2000 control (Fenwal, Inc.). FFP was prepared from WB held at room temperature more than 6 hours and placed at less than −18°C by 8 hours for control (n = 60) and test (n = 60) arms. PF24RT24WB (n = 60) was prepared with the test system from WB held at room temperature and then filtered and processed 20 to 24 hours postcollection. Frozen plasma was tested at 3, 6, and 12 months using a comprehensive panel of protein and coagulation factor assays. RESULTS: The test FFP was BE for all coagulation factors and tested proteins at 12 months. As expected, PF24RT24WB had a reduced Factor (F)VIII activity compared to control FFP (87.1%; 90% confidence interval, 79.4%-93.3%) with the lower confidence limit less than 80%. All other factors were within the BE region. CONCLUSION: Leukoreduced FFP and PF24RT24WB prepared using the LEUKOSEP HWB-600-XL system has been shown to be BE to control leukoreduced FFP with an expected decrease in FVIII activity after overnight hold.