Background: Randomized clinical trial data show that early plasma transfusion may save lives among trauma patients. Supplying plasma in remote environments is logistically challenging. Freeze-dried plasma (FDP) offers a possible solution.Study Design and Methods: A Terumo BCT plasma freeze-drying system was evaluated. We compared pooled frozen plasma (FP) units with derived Terumo BCT FDP (TFDP) units and pooled COVID-19 convalescent apheresis fresh-frozen plasma (CC-AFFP) with derived CC-TFDP units. Parameters measured were: coagulation factors (F) II; V; VII; VIII; IX; XI; XIII; fibrinogen; Proteins C (PC) and S (PS); antithrombin (AT); α 2 -antiplasmin (α 2 AP); ADAMTS13; von Willebrand Factor (vWF); thrombin-antithrombin (TAT); D-dimer; activated complement factors 3 (C3a) and 5 (C5a); pH; osmolality; prothrombin time (PT); and activated partial thromboplastin time (aPTT).Antibodies to SARS-CoV-2 in CC-AFFP and CC-TFDP units were compared by plaque reduction assays and viral protein immunoassays. Results: Most parameters were unchanged in TFDP versus FP or differed ≤15%. Mean aPTT, PT, C3a, and pH were elevated 5.9%, 6.9%, 64%, and 0.28 units, respectively, versus FP. CC-TFDP showed no loss of SARS-CoV-2 neutralization titer versus CC-AFFP and no mean signal loss in most pools by viral protein immunoassays.

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Background and Objectives Frozen plasma (FP) is thawed prior to transfusion and stored for ≤5 days at 1–6°C. The effect of temperature excursions on the quality and safety of thawed plasma during 5‐day storage was determined. Materials and Methods Four plasma units were pooled, split and stored at ≤−18°C for ≤90 days. Test units T30 and T60 were exposed to 20–24°C (room temperature [RT]) for 30 or 60 min, respectively, on days 0 and 2 of storage. Negative and positive control units remained refrigerated or at RT for 5 days, respectively. On Day 5, test units were exposed once to RT for 5 h. Quality assays included stability of coagulation factors FV, FVII, FVIII, fibrinogen and prothrombin time. Bacterial growth was performed in units inoculated with ~1 CFU/ml or ~100 CFU/ml of Serratia liquefaciens, Pseudomonas putida, Pseudomonas aeruginosa or Staphylococcus epidermidis on Day 0. Results Testing results of all quality parameters were comparable between T30 and T60 units (p < 0.05). Serratia liquefaciens proliferated in cold‐stored plasma, while P. putida showed variable viability. Serratia epidermidis and P. aeruginosa survived but did not grow in cold‐stored plasma. Positive and negative controls showed expected results. Overall, no statistical differences in bacterial concentration between T30 and T60 units were observed (p < 0.05). Conclusion Multiple RT exposures for 30 or 60 min do not affect the stability of coagulation factors or promote bacterial growth in thawed plasma stored for 5 days. It is therefore safe to expose thawed plasma to uncontrolled temperatures for limited periods of 60 min.

BACKGROUNDCryopreserved red blood cell concentrates (RCCs) are often required for patients with rare blood groups. Although transfusions from blood relatives are irradiated before transfusion, research has yet to make clear if this is necessary in cryopreserved RCCs. Given insufficient evidence to the contrary, irradiation of cryopreserved RCCs has been recommended, but the effect of irradiation timing is unknown. Therefore, this study was performed to assess the effect of RCC irradiation pre‐ and postcryopreservation on RCC quality.STUDY DESIGN AND METHODSNine whole blood units from healthy donors were processed into RCCs using the buffy coat method. ABO‐ and Rh‐matched units were pooled and split into three groups: precryopreservation irradiation (pre‐CIG), postcryopreservation irradiation (post‐CIG), and nonirradiated controls. Hemoglobin, hematocrit, white blood cell (WBC) count, extracellular potassium, mean cell volume, red blood cell (RBC) morphology, and RBC deformability were measured.RESULTSExtracellular potassium was greater in the irradiated conditions when compared to the nonirradiated controls and was greater in the post‐CIG group when compared to the pre‐CIG group (p < 0.05). WBC counts decreased after cryopreservation in all groups to values lower than the sensitivity of the assay. RBC deformability was greater in the post‐CIG group when compared to the pre‐CIG group and control group. No other significant differences were observed between groups.CONCLUSIONIrradiation of RCCs can be performed pre‐ or postcryopreservation with little effect on the RCC product, as both irradiated groups resulted in RCCs that were comparable to the nonirradiated cryopreserved RCCs.

Background Differences in manufacturing conditions using the Haemonetics ACP 215 cell processor result in cryopreserved red cell concentrates (RCCs) of varying quality. This work studied the effect of processing method, additive solution, and storage duration on RCC quality to identify an optimal protocol for the manufacture of cryopreserved RCCs. Materials and methods RCCs were pooled‐and‐split and stored for 7, 14, or 21 days before cryopreservation. Units were glycerolized with the ACP 215 using a single or double centrifugation method. After thawing, the RCCs were deglycerolized, suspended in AS‐3, SAGM, ESOL, or SOLX/AS‐7, and stored for 0, 3, 7, 14, or 21 days before quality testing. Quality assessments included hemoglobin content, hematocrit, hemolysis, adenosine triphosphate (ATP), supernatant potassium, and mean cell volume. Results Both glycerolization methods produced RCCs that met regulatory standards for blood quality. Dual centrifugation resulted in higher hemoglobin content, fewer processing alerts, and a shorter deglycerolization time than single centrifugation processing. Units processed with AS‐3 and ESOL met regulatory standards when stored for up to 21 days pre‐cryopreservation and 21 days post‐deglycerolization. However, ESOL demonstrated superior maintenance of ATP over RBCs in AS‐3. Some RCCs suspended in SAGM and SOLX exceeded acceptable hemolysis values after 7 days of post‐deglycerolization storage regardless of pre‐processing storage length. Conclusions When manufacturing cryopreserved RCCs using the ACP 215, dual centrifugation processing with AS‐3 or ESOL additive solutions is preferred, with storage periods of up to 21 days both pre‐processing and post‐deglycerolization.