Vox sanguinis · 2026
In vitro and in vivo evaluation of leukoreduced red cell concentrates stored in non-DEHP storage bags.
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van Wonderen Stefan F, Vermeulen Christie, Lagerberg Johan, van Amstel Rombout B E, Ribble Leeann, Sedjo Rebecca L, Rhodes Jack, Clymer E Jane, Vlaar Alexander P J, Klei Thomas R L
Аннотация
BACKGROUND AND OBJECTIVES: Europe will ban di(2-ethylhexyl) phthalate (DEHP), used in blood bags, after 1 July 2030. This two-phase study assessed the in vitro quality and in vivo 24-h post-transfusion recovery (PTR) of whole blood-derived leukoreduced red cell concentrates (RCCs) collected and processed in 1,2-cyclohexane dicarboxylic acid diisononyl ester (DINCH)-plasticized sets and stored for 42 days in non-DEHP Erythromate-plasticized, a proprietary blend of DINCH and N-butyryl-tri-n-hexyl citrate (BTHC), disposable sets.
MATERIALS AND METHODS: In Phase 1, in vitro parameters of RCCs (n = 32) stored in non-DEHP sets containing phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) were compared with those of RCCs stored in DEHP sets containing saline-adenine-glucose-mannitol (SAGM) (n = 24). These parameters were assessed against the European Directorate for the Quality of Medicines & Health Care (EDQM) criteria. In Phase 2, PTR of 42-day autologous non-DEHP RCCs was evaluated using biotin-labelled methods in 24 healthy participants and compared against the EDQM and the US Food and Drug Administration (FDA) criteria.
RESULTS: Phase 1 results showed that haemoglobin concentrations remained stable. Haemolysis in non-DEHP/PAGGSM disposable sets was below the EDQM limit (<0.8%) with a 95% confidence limit (CL) of 0.25% on Day 42 and was significantly lower (0.22% ± 0.11%) compared to DEHP/SAGM (0.31% ± 0.14%). In Phase 2, PTR exceeded the 75% threshold set by the EDQM and FDA in all infusions (lower CL: 88.3%), with a mean of 93.3% ± 6.7%.
CONCLUSION: RCCs stored in non-DEHP/PAGGSM disposable sets met the in vitro EDQM criteria for quality and in vivo EDQM and FDA criteria for transfusable RCCs, thereby providing a suitable alternative to current DEHP-plasticized disposable sets.
TRIAL REGISTRATION: The clinical trial was registered at the World Health Organization-International Clinical Trials Registry Platform (ICTRP): NL-OMON56734, registration date 30 April 2024.
MATERIALS AND METHODS: In Phase 1, in vitro parameters of RCCs (n = 32) stored in non-DEHP sets containing phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) were compared with those of RCCs stored in DEHP sets containing saline-adenine-glucose-mannitol (SAGM) (n = 24). These parameters were assessed against the European Directorate for the Quality of Medicines & Health Care (EDQM) criteria. In Phase 2, PTR of 42-day autologous non-DEHP RCCs was evaluated using biotin-labelled methods in 24 healthy participants and compared against the EDQM and the US Food and Drug Administration (FDA) criteria.
RESULTS: Phase 1 results showed that haemoglobin concentrations remained stable. Haemolysis in non-DEHP/PAGGSM disposable sets was below the EDQM limit (<0.8%) with a 95% confidence limit (CL) of 0.25% on Day 42 and was significantly lower (0.22% ± 0.11%) compared to DEHP/SAGM (0.31% ± 0.14%). In Phase 2, PTR exceeded the 75% threshold set by the EDQM and FDA in all infusions (lower CL: 88.3%), with a mean of 93.3% ± 6.7%.
CONCLUSION: RCCs stored in non-DEHP/PAGGSM disposable sets met the in vitro EDQM criteria for quality and in vivo EDQM and FDA criteria for transfusable RCCs, thereby providing a suitable alternative to current DEHP-plasticized disposable sets.
TRIAL REGISTRATION: The clinical trial was registered at the World Health Organization-International Clinical Trials Registry Platform (ICTRP): NL-OMON56734, registration date 30 April 2024.