ArticleVox sanguinis2025
In vitro quality of whole blood-derived red cell concentrates collected, processed and stored in a blood bag set plasticized with di (2-ethylhexyl) terephthalate.
Article in Vox sanguinis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- In vitro evaluation of apheresis platelet and plasma products collected and stored in non-DEHP disposable sets.Vox sanguinis · 2026Trial
- Bacterial proliferation is comparable in red blood cell concentrates stored in DEHT/PAGGSM and DEHP/SAGM containers.Vox sanguinis · 2026Article
- In vitro quality assessment of red blood cells and plasma units in DEHT/SAGM bags and DEHT/PAGGSM bags during storage.Vox sanguinis · 2026Article
- In vitro quality of whole blood-derived red cell concentrates collected, processed and stored in a blood bag set plasticized with di (2-ethylhexyl) terephthalate.Vox sanguinis · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesDue to toxicity concerns, di(2-ethylhexyl) phthalate (DEHP)-the most used plasticizer in polyvinyl chloride (PVC) whole blood (WB) collection and processing bag sets-will be effectively prohibited in medical devices in Europe from 2030. Removal of DEHP will primarily impact the in vitro quality of red blood cell (RBC) concentrates (RCCs) and DEHP-free sets with alternate additive solutions (ASs) that better preserve RBCs in the absence of DEHP are being developed. This study compared the in vitro quality of RCCs from di (2-ethylhexyl) terephthalate (DEHT)/phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) and DEHP/saline-adenine-glucose-mannitol (SAGM) sets. MATERIALS AND
methodsWB was collected into citrate-phosphate-dextrose (CPD) in either 500-mL DEHP/SAGM (n = 37) or prototype 475-mL DEHT/PAGGSM bag sets (n = 29). Leucoreduced (LR)-RCCs were produced using semi-automated top/bottom processing within 24 h of collection. RBC quality, including haemolysis, supernatant metabolic parameters and RBC deformability, was measured on D43 (1-day after expiry).
resultsAll RCCs in the study had haemolysis <0.8%, and there was no statistically significant difference between haemolysis in DEHT/PAGGSM and DEHP/SAGM RCC (p = 0.083). Tolerance bound analysis indicated that RCCs in DEHT/PAGGSM produced using Canadian Blood Services' main production method would meet current Canadian Standards Association (CSA) CAN/CSA-Z902:25 quality control (QC) requirements for RCCs. There were some differences in metabolic in vitro quality measures, and RBCs in DEHT/PAGGSM were slightly less deformable (lower maximum elongation index [EI
conclusionRBCs have acceptable in vitro quality at expiry in DEHT/PAGGSM, supporting a 42-day shelf life.
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