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
Bibliographic record
Abstract
Abstract Background and Objectives Due 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 Methods WB 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). Results All 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 MAX ]) and required larger amounts of force ( K EI ) to physically deform. Conclusion RBCs have acceptable in vitro quality at expiry in DEHT/PAGGSM, supporting a 42‐day shelf life.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".