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Background and Objectives: Di‐ethyl‐hexyl‐phthalate (DEHP) is currently the main plasticizer used for whole blood collection systems. However, in Europe, after May 2025, DEHP may no longer be used above 0.1% (w/w) in medical devices. DEHP stabilizes red cell membranes, thereby suppressing haemolysis during storage. Here we compared in vitro quality parameters of red cell concentrates (RCCs) collected and stored in DEHP‐, DINCH‐ or DINCH/BTHC‐PVC hybrid blood bags with saline‐adenine‐glucose‐mannitol (SAGM) or phosphate‐adenine‐glucose‐guanosine‐saline‐mannitol (PAGGSM) storage solution. Last, we performed haemovigilance surveillance for RCC collected in DINCH‐PVC and stored in PAGGSM/BTHC‐PVC. Materials and Methods: In vitro quality parameters of RCC were determined during 42 days of storage. Haemovigilance surveillance was conducted to compare the frequency and type of transfusion reaction. Results: Haemolysis levels were increased in SAGM/BTHC‐PVC as compared to SAGM/DEHP‐PVC (0.66% ± 0.18% vs. 0.36% ± 0.17%). PAGGSM storage solution was able to adequately suppress haemolysis to levels observed during storage in SAGM/DEHP‐PVC, both in BTHC‐PVC (0.38% ± 0.12%), and to a slightly lesser extent in DINCH‐PVC (0.48% ± 0.17%). A total of 1650 PAGGSM/BTHC‐PVC and 5662 SAGM/DEHP‐PVC RCC were transfused yielding a transfusion reaction frequency of 0.24% (95% CI 0.0000–0.0048) and 0.44% (95% CI 0.0027–0.0061) respectively. Conclusion: The in vitro quality of RCC stored in PAGGSM/BTHC‐PVC and SAGM/DEHP‐PVC is comparable. There is no indication that transfusion of erythrocytes stored in PAGGSM/BTHC‐PVC results in increased transfusion reaction frequency. These initial results provide a basis for further clinical evaluation to narrow down the confidence interval of transfusion reaction frequency. [ABSTRACT FROM AUTHOR]

Purpose: Cell salvage is the process by which blood lost in surgery is collected and washed or filtered to produce autologous blood for re-transfusion to the patient. Cell salvage aims to reduce the need for donor blood. Centrifugal cell salvage washing technique is a preferred medical treatment in order to retain lost red blood cells (RBCs) without contaminants. Although this technology very efficiently collects and washes shed blood, it is costly and often impractical or unavailable, especially in middle- or low-income countries. This study assessed two innovative filter devices as an alternative to centrifugal cell salvage technology: a coarse collection filter device (Hemafuse) and a microfiltration device (HemoClear). In contrast to centrifugal technology, both filter devices do not require electricity, nor costly equipment and extensive training. We compared the effectiveness of these filtration technologies to remove plasma constituents and recover and concentrate the cellular components with centrifugal technology (autoLog® device). Methods: Whole blood was processed with each technology according to the device manufacturer's instructions. Before and after processing, the blood products were analyzed for supernatant solutes and cellular composition. Results: The centrifugal technology confirmed its efficacy to remove potentially harmful solutes and capture red blood cells. The microfiltration technology (HemoClear) reached comparable levels of removal of solutes, with a potential advantage over centrifugal technology in the ability to also recover platelets. The coarse filtration technology (Hemafuse) had no washing capacity but, like the microfiltration technology, has the advantage of recovering platelets. Conclusion: Innovative filtration devices represent an alternative to centrifugal technology in the preparation of autologous blood for reinfusion. The HemoClear technology for the first time enables the recovery of washed platelets and red blood cells. Clinical trials will have to be performed to investigate the clinical value of this new autologous blood product. [ABSTRACT FROM AUTHOR]

Objectives: Our objectives were to determine the separation characteristics and blood product quality of a gravity‐driven microfiltration blood separation system (HemoClear, The Netherlands). Background: A range of centrifugal blood separation devices, including intraoperative cell salvage devices (cell savers) and apheresis machines, are available to assist in preparing both allogenic and autologous blood products. These devices are expensive to operate and require extensive training. Methods and Materials: Nine whole blood units were collected under standard conditions and analysed for haematological parameters, thromboelastographic properties, platelet morphology and activation, and red blood cell (RBC) deformability and morphology. Three whole blood units were separated by means of the HemoClear device, into a liquid and cellular component. The cellular component was diluted with SAGM and cold stored for 14 days. To simulate cell salvage six whole blood units were diluted with isotonic saline, followed by multiple HemoClear separation rounds. Results: The recovery of both RBCs (100 ± 1.6%) and white blood cells (99 ± 4.5%) after undiluted filtration were very high, while platelet recovery was high (83 ± 3.0%). During the filtration, and cold storage after filtration storage both the non‐deformable RBC fraction and the RBC maximum elongation remained stable. Parameters of thromboelastography indicated that platelets remain functional after filtration and after 7 days of cold storage. In the cell salvage simulation the total protein load in the cellular fraction was reduced by 65 ± 4.1% after one washing round and 84 ± 1.9% after two consecutive washing rounds. Conclusion: The novel blood filter studied effectively separates whole blood into diluted plasma and platelet‐rich RBCs. Moreover, the device effectively washed diluted whole blood, driving over 80% of proteins to the liquid component. [ABSTRACT FROM AUTHOR]

Background: Manufacture of platelet concentrates (PCs) and plasma may fail to remove all residual red blood cells (rRBCs). Measuring rRBCs for compliance to guidelines has proven challenging, leading to an absence of a consensus methodology. Sysmex hematology analyzers with the Blood Bank mode (BB mode) analysis option offer the potential for automated rRBC counting. We therefore performed a two‐site appraisal of the system. Study Design and Methods: Performance characteristics were determined using platelet and plasma samples spiked with RBCs. Sample stability (n = 47) and the impact of sample type were also assessed. Components (platelets, n = 1474; plasma, n = 77) prepared using different routine manufacturing methods were tested to assess variation in rRBC concentration. Results: Linearity studies up to 19 000 RBCs/μL demonstrated good correlation between expected and observed results (R2 ≥ 0.9731), and flow cytometric results also correlated well with BB mode (R2 = 0.9400). Precision analysis gave a limit of quantitation of 6 to 7 RBCs/μL, and carryover was 0.03%. Ethylenediaminetetraacetic acid and plain tube results were not significantly different (P ≥ 0.10), and samples were stable up to 24 hours. Apheresis PCs produced at two sites had lower rRBC concentrations (medians, 17 and 13 RBCs/μL) than those produced with the buffy coat method either manually (median, 681 RBCs/μL) or with the automated Terumo Automated Centrifuge and Separator Integration process (median, 81 RBCs/μL). All PCs failing visual inspection as having RBCs ≥4000 RBCs/μL were also detected by the BB mode. Conclusion: The BB mode had acceptable performance characteristics and has the potential for integration into a fully automated process control system for rRBC enumeration in plasma and PCs. [ABSTRACT FROM AUTHOR]

Introduction: Several studies indicate that lipemic plasma can have an adverse effect on the quality of platelets and red blood cell concentrates (RCC) during storage. The aim of this study was to expand the knowledge of donor characteristics in relation to RCC storage quality. Materials and methods: Donor characteristics of lipemic whole blood (WB) donations were obtained. As control, historical data on donor characteristics were used. RCCs in SAGM were produced from these lipemic WB donations, and in vitro quality during cold storage was determined. In plasma, triglyceride levels were determined. Results were compared with normal, non‐lipemic donations. Results: A total of 26 lipemic WB donations were evaluated of which only two were obtained from a female donor. Mean age of donors in this study was 50 years. A total of 18 donors (69%) showed overweight (BMI 25–30) or were obese (BMI > 30). Lipemic donations were drawn between 2:40 and 8:40 PM, with 22 donations after 6:00 PM. Triglyceride levels in lipemic plasma were on average 5·9 mmol/L. At day 42 of storage, the lipemic group showed significant higher haemolysis (1·24 ± 0·82%), as compared to the control group (0·30 ± 0·14%). Discussion: Haemolysis during storage was greatly enhanced in RCCs from lipemic WB donations. Based on the limited set of donations in this evaluation, a tentative conclusion is that highest chance of lipemic plasma exists in donations from men over 50 years with BMI > 25, donating in the evening. Based on these investigations, our blood service decided not to use lipemic WB for the production of (cellular) blood products. [ABSTRACT FROM AUTHOR]

Background The plasticizer di(2-ethylhexyl)phthalate ( DEHP) is a common component in blood bags. DEHP is noncovalently bound to polyvinylchloride ( PVC) polymer and can leach into the blood product. There are public concerns that exposure to DEHP might induce developmental and reproductive toxicity in humans. The aim of this study was to evaluate an alternative plasticizer, di(isononyl) cyclohexane-1,2-dicarboxylate ( Hexamoll DINCH, BASF SE), for its use in blood bags. Study Design and Methods Whole blood ( WB) was collected into DEHP-containing and DEHP-free collection systems. After overnight hold, WB was centrifuged and separated in plasma, buffy coat, and red blood cells ( RBCs). Buffy coats and plasma were used to make platelet (PLT) concentrates in DEHP-free systems. After addition of additive solution ( AS), SAG- M, PAGGS- M, AS-3, or PAGGG- M, RBCs were leukoreduced and analyzed for in vitro characteristics and plasticizer levels during storage. Results The use of DINCH-based systems had no effect on WB composition, blood processing, and plasma quality. PLT in vitro quality variables were maintained during storage in DEHP-free systems. During storage in SAG- M, hemolysis was significantly higher in DINCH- PVC while potassium leakage and adenosine triphosphate content were comparable. During storage in alternative ASs, hemolysis was reduced compared to storage in SAG- M. Conclusions The complete absence of DEHP in the collection system had no effect on WB composition, processing, or plasma and PLT quality. During storage in SAG- M, the absence of DEHP resulted in increased hemolysis. With alternative ASs like PAGGS- M, AS-3, or PAGGG- M, the absence of DEHP had no effect on hemolysis. Leakage of DINCH into the blood product was less pronounced than that of DEHP. [ABSTRACT FROM AUTHOR]

Background The Reveos system ( Terumo BCT) is a fully automated device able to process four whole blood ( WB) units simultaneously into a plasma unit, a red blood cell ( RBC) unit, and an interim platelet ( PLT) unit ( IPU). Multiple IPUs can be pooled to form a transfusable PLT product. The aim of our study was to evaluate the quality of components made with the Reveos system from either fresh (2-8 hr) or overnight-held WB. Study Design and Methods A prototype of the Reveos system was used to process WB. RBCs were resuspended in SAGM, leukoreduced, and assayed for in vitro quality variables during a 42-day storage period at 2 to 6° C. Twenty-four-hour in vivo recovery was determined on Day 42. Plasma was assayed for cellular contamination and activation variables. IPUs were pooled with SSP+ additive solution for in vitro quality assessments during a 7-day storage period at room temperature. Results Reveos-produced RBCs and plasma units met the predefined requirements. RBC recovery was superior to control units. On Day 42, hemolysis was below 0.8% and in vivo recovery was above 75% for all RBCs. Cellular contamination was lower for Reveos-produced plasma. PLT yield was higher with overnight-stored WB. PLT quality was well maintained during storage with no significant differences between the two groups. Conclusion Blood components prepared with the Reveos from fresh or overnight-held WB meet quality criteria without any relevant difference between the two groups. The Reveos system has the potential to increase efficacy and standardization of blood component preparation. [ABSTRACT FROM AUTHOR]

In transfusion medicine, frozen red blood cells (RBCs) are an alternative for liquid-stored RBCs. Little is known about the rheologic properties (i.e., aggregability and deformability) of thawed RBCs. In this study the rheologic properties of high-glycerol frozen RBCs and postthaw stored in saline-adenine-glucose-mannitol medium were compared to those of conventionally liquid-stored and fresh RBCs. Fresh RBCs were obtained from healthy volunteers. Leukoreduced liquid-stored and thawed deglycerolized RBC units were obtained from the Sanquin Blood Bank. RBCs were tested for aggregability (aggregation index [AI]), deformability (elongation index [EI]), and various hematologic variables. The AI of thawed RBCs was reduced, compared to fresh and liquid-stored RBCs (p < 0.05). The EI of stored RBCs was significantly enhanced over a shear stress range of 2.0 to 50 Pa compared to fresh RBCs (p < 0.05). No significant differences in EI between thawed and 21- or 35-day liquid-stored RBCs were observed. The osmotic fragility, hemolysis, mean cell volume, and mean cell hemoglobin concentration of thawed RBCs were markedly altered, compared to fresh and liquid-stored RBCs (p < 0.05). The adenosine triphosphate (ATP) content of thawed RBCs was similar to 3- or 21-day liquid-stored and fresh RBCs. Thawed RBCs are more fragile than conventionally liquid-stored and fresh RBC. The freeze-thaw-wash process, however, did not adversely affect the aggregability and deformability or the ATP content of thawed RBCs. Based on the rheologic properties, cryopreserved RBCs are a valuable alternative to liquid-stored RBCs. [ABSTRACT FROM AUTHOR]

BACKGROUND: The freezing curve currently used for the cryopreservation of peripheral blood stem cell transplants (PBSCTs) has been determined empirically. Although the use of cryopreserved PBSCTs is successful and usually leads to rapid hematopoietic recovery, the freeze-thawing process is known to induce a significant degree of cell death. Furthermore, the infusion of dimethyl sulfoxide (DMSO), used to protect the cells against damage induced by freezing, can cause morbidity. Therefore, optimizing the current cryopreservation protocol (with 10% DMSO and a slow linear cooling curve) with theoretically optimized freezing curves and a lower DMSO concentration might improve the recovery after transplantation. STUDY DESIGN AND METHODS: A theoretical model was used to predict optimal freezing curves for 5 and 10 percent DMSO. CD34+-selected and -unselected PBSCs were cryopreserved with the current or the new freezing curves. Postthaw quality was evaluated by cell viability, colony formation, and megakaryocyte outgrowth. RESULTS: With 10 percent DMSO, the use of the predicted optimal freezing curve resulted in increased postthaw viability of CD34+ cells, colony formation, and megakaryocyte outgrowth. Lowering the DMSO concentration to 5 percent resulted in improved postthaw viability and functionality, which was not further improved by use of the theoretically optimized freezing curve. CONCLUSIONS: Our results indicate that the current cryopreservation method for PBSCTs can be improved by either lowering the DMSO concentration to 5 percent or by using the theoretically optimized freezing curve. Infusion of less DMSO and more viable cells might improve the outcome of PBSCT. [ABSTRACT FROM AUTHOR]

BACKGROUND: The use of a functionally closed system (ACP215, Haemonetics) for the glycerolization and deglycerolization of red blood cell (RBC) units allows for prolonged postthaw storage. In this study, the postthaw quality of previously frozen, deglycerolized RBCs resuspended in saline-adenine-glucose-mannitol (SAGM) or additive solution AS-3 was investigated. STUDY DESIGN AND METHODS: Leukoreduced RBC units were frozen with 40 percent glycerol and stored at −80°C for at least 14 days. The thawed units were deglycerolized with the ACP215, resuspended in SAGM or AS-3, and stored at 2 to 6°C for up to 21 days. RESULTS: The mean ± standard deviation in vitro freeze-thaw-wash recovery was 81 ± 5 percent. During storage, hemolysis of deglycerolized cells remained below 0.8 percent for 2 days in SAGM and for 14 days in AS-3. This difference was explained by the protective effect of citrate, which is present in AS-3. Cells stored in AS-3 showed a lower glycolytic activity and a faster decline in adenosine 5′-triphosphate (ATP) than cells in SAGM. Increasing the internal pH of cells before storage in AS-3 by use of phosphate-buffered saline (PBS) in the deglycerolization procedure resulted in elevated lactate production and better maintenance of intracellular ATP content. After 3 weeks of storage, the ATP content of PBS-washed cells amounted to 2.5 ± 0.5 µmol per g of hemoglobin (Hb), whereas for saline/glucose-washed cells this value was decreased to 1.0 ± 0.3 µmol per g of Hb. CONCLUSIONS: Leukoreduced, deglycerolized RBCs can be stored for 48 hours in SAGM. Improved ATP levels during refrigerated storage can be observed with thawed cells, resuspended in AS-3, when PBS is used as a washing solution. [ABSTRACT FROM AUTHOR]

Photodynamic treatment could be a way to inactivate pathogens in RBCs. The objective of this study was to characterize the virucidal activity and RBC-damaging activity of a series of cationic porphyrins. Using the most efficacious photosensitizer, various in-vitro human RBC quality variables and in-vivo RBC survival in Rhesus monkeys were evaluated. RBCs, spiked with 5 log of extracellular VSV, were treated with porphyrins (25 µmol/L) and red light (100 W/m2) and essayed for virucidal activity. In-vitro RBC quality variables were assessed during 5 weeks of storage in various ASs. In-vivo survival was investigated with autologous RBCs in Rhesus monkeys. Tri-P(4) was by far the best sensitizer of a series tested, giving the least hemolysis under conditions that resulted in 5 log-kill of extracellular VSV. Under our experimental conditions, the percentage hemolysis in treated cells was 5.1 ± 1.1 percent after 5 weeks of storage in SAG-M compared to 1.9 ± 1.1 percent in the untreated control. Storage in AS-3 resulted hemolysis of 2.3 ± 1.9 percent. With the exception of IgG binding and potassium leakage, RBC quality variables remained unchanged after photodynamic treatment. Addition of reduced glutathione (GSH) during treatment reduced IgG binding. The 24-hour recovery and T50 of treated RBCs in Rhesus monkeys were satisfactory. Porphyrin Tri-P(4) may be a suitable photosensitizer for sterilization of RBCs. However, further exploration to optimize the method is necessary to reach clinically acceptable goals. [ABSTRACT FROM AUTHOR]