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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]

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: Apheresis is increasingly being applied to collect cells or plasma, even allowing the collection of multiple blood components during one procedure. Although the quality of the cellular and plasma products that are obtained by apheresis have been extensively studied and shown to be of high quality, the impact of apheresis on the red blood cells (RBCs) that are returned to the donor has not been investigated.Study Design and Methods: The effect of the plasma- or plateletpheresis procedures by four different devices-MCS+ (Haemonetics), PCS2 (Haemonetics), Trima Accel (Terumo BCT), and Autopheresis-C (Auto-C, Fresenius Kabi)-on the RBCs that are returned to the donor was tested in a blinded, prospective trial in a cohort of 25 donors.Results: A rheologic analysis of donor RBCs before and after plasma- or plateletpheresis showed no differences in outcome. However, a strong increase in hemolysis was found in samples from the Trima Accel devices after plateletpheresis, compared to all other machines tested. Furthermore, an increase in complement deposition on RBCs was seen after all plasmapheresis procedures (MCS+, PCS2, and Auto-C). Finally, a significant decrease in the expression of the complement-regulating protein CD59 was seen in all postapheresis samples as well as a significant decrease of the adhesion molecule CD147.Conclusion: The increase in complement deposition and the decrease in the expression of CD59 suggests that RBC clearance might be enhanced after return to the donor. Possible side effects due to an increase in hemolysis after Trima Accel plateletpheresis should be further investigated. [ABSTRACT FROM AUTHOR]