OA2-AM24-ST-13 - In Vitro Quality of RBCs in PAGGS-M Prepared in Non-DEHP Bag Systems: Influence of Weekly Mixing

Di-ethyl-hexyl-phthalate (DEHP) is currently one of the most common plasticizers used in blood bags. Due to its endocrine disrupting properties European regulators decided to ban its use in medical devices until 2030. Thus, the introduction of non-DEHP blood bags will be mandatory in Europe within the next years. DEHP stabilizes red cell membranes, thereby reducing hemolysis during storage. Different plasticizer like DEHT, DINCH and/or BTHC replacing DEHP in the future will potentially influence the quality (mainly hemolysis) and shelf life of red cell concentrates (RCC) collected in non-DEHP bag systems. It was shown in the past that weekly mixing might reduce the hemolysis rate of RCC stored in DINCH-containing bags. In the current study we evaluated the quality of RCC donated and processed in a DINCH-containing bag and stored in a BTHC-containing bag.

Study

Design/Methods:

Whole blood units (WB, 500 mL in 70 mL CPD) were collected in a CE-certified DINCH/BTHC-PVC hybrid blood bag system (REF FQ42271, Fresenius Kabi) and were kept at room temperature (22±2°C) overnight. On the next day (day 1), RCC were processed by high-speed centrifugation (Roto Silenta 630 RS/63 RS; Hettich, Tuttlingen, Germany) followed by automated blood component separation (Macopress Smarter; Macopharma). RCC were diluted in 110 mL additive solution PAGGS-M and leukoreduced by filtration. Pools (n=6) of two RCC each were prepared and split again into two storage bags composed of BTHC-PVC. RCC units were stored at 4 ± 2 °C for 43 days. One RCC of each pool was mixed and sampled weekly, while the other remained without mixing for 43 days.

Results/Findings:

RCC were in accordance with German guidelines with a hematocrit of 57.0 ± 0.8 %, total hemoglobin of 51.3 ± 2.4 g/unit and residual WBC < 1 x 10⁶/unit. Quality parameters are shown in Table 1. Hemolysis was significantly decreased in RCC mixed weekly in comparison to non-mixed RCC (0.24 ± 0.05% vs. 0.41 ± 0.09%, p = 0.0038). Hemolysis however was well below the threshold of 0.8% requested by the German as well as European guidelines with or without mixing until day 43. Only small differences were shown between the two arms with respect to pH, potassium, glucose, lactate and osmotic fragility.

Conclusions:

In vitro quality of RCC collected and stored in the CE-certified DINCH/BTHC-PVC hybrid blood bag system (REF FQ42271, Fresenius Kabi) were in accordance with the German as well as European guidelines until day 43 of storage. The hemolysis rate was influenced by weekly mixing of the storage bag during sampling. Results have to be considered in the design of future validations studies avoiding weekly sampling in order to receive realistic quality data at the end of shelf life.