In vitro Qualitätsanalyse von Erythrozyten bei Lagerung in DEHP (bis(2-ethylhexyl) phthalate)-haltigen Blutbeuteln für die Pädiatrie im Vergleich zum alternativen Weichmacher DINCH (cyclohexane-1,2-dicarboxylic acid)
Hannah Döpper (Hagen / DE), Mario Majchrzak (Hagen / DE), Carlos Luis Jiménez Klingberg (Hagen / DE), Andreas Grolle (Hagen / DE), Robert Deitenbeck (Hagen / DE), Lambros Kordelas (Hagen / DE)
DEHP is a plasticizer used in blood bags for decades but has been classified as CMR (cancerogenic, mutagenic, reprotoxic). Under the REACH regulation, manufacturers are obliged to remove DEHP from their products until December 2027. There is only limited in vitro data for red blood cell concentrates (RBCC) stored in blood bags containing alternative plasticizers. Data published so far indicates that the alternatives do not achieve the same quality characteristics as DEHP-containing blood bags.
We compared red blood cells (RBC) stored in a standard blood bag system containing DEHP with a DEHP-containing alternative and a DEHP-free blood bag containing DINCH as plasticizer. We also analyzed the quality of γ-irradiated RBCC in the different blood bags. To create identical RBC content, RBCC in additive solution (PAGGS-M) were pooled and split into the three different blood bags. Storage effects were assessed on day 1 of storage (baseline) as well as on days 11, 22, 31, 38 and 43 for the non-irradiated RBC and on days 2, 6, 8, 13 and 15 for the γ-irradiated RBC.
The following quality parameters were analyzed: potassium, hemolysis rate, ATP concentration and glucose/lactate concentration. For both study arms, irradiated and non-irradiated, our data demonstrates that although the hemolysis rate increases over time, it does not approach the limit value of 0.8%, even at the end of the shelf life. The same applies to the potassium release in non-irradiated RBCC: the concentration increases over time but does not exceed the limit value of 70 mmol/l. Only irradiated RBCC in DEHP/F and DINCH/F bags exceeded the potassium threshold on day 15. ATP levels were maintained at identical levels in all three blood bags. Moreover, metabolic rates did not differ among the blood bags.
Hence, our results demonstrate that RBC in blood bags with the alternative plasticizer DINCH have a comparable quality over their shelf life to RBC in blood bag systems with DEHP (irradiated and non-irradiated). Nevertheless, the manufacturer suggests that the shelf life of non-irradiated RBCC stored in blood bags containing DINCH should be limited to a maximum of 28 days. Therefore, the longer shelf life of 42 days will be subject to further testing.
The authors have no conflicts of interest to declare.