Comparative study on the quality of blood products collected and stored in blood bag systems with and without DEHP

Di(2-ethylhexyl) phthalate (DEHP) is an organic compound used to make blood bag systems (BBS) flexible. Concerns about possible endocrine-disruptive effects have led to European legislation aiming to ban the use of these plasticizers. However, dissolved DEHP has a beneficial effect in maintaining red blood cell (RBC) stability. The objective of this study was to collect quality data of blood products stored in BBS with and without DEHP and of RBCs resuspended in different additive solutions.

Whole blood was collected and stored in BBS (Fresenius Kabi) with different combinations of plasticizers and RBC additive solutions (A: DEHP-SAGM, B: DEHP-PAGGSM, C: DINCH/BTHC/DEHT-PAGGSM). Collection and processing of the resulting blood products were performed under routine-like conditions. Manufacturing steps were monitored and evaluated. The collection of quality parameters was based on the requirements of the local guidelines and the recommendations of the European Blood Alliance with a strong focus on the quality and shelf-life of RBCs. RBC samples were collected weekly until day 50 after collection. Testing for in vitro quality characteristics was performed according to local standard operation procedures.

Leucoreduction filtration times were prolonged in RBCs resuspended in PAGGSM (B: 32.3 ± 6.2 min, C: 34.4 ± 6.8 min) compared to the SAGM group (A: 26.3 ± 4.7 min). Group C (DEHP-free) maintained higher ATP levels during storage time than the other two groups (DEHP, A: 1.88 ± 0.50 µmol/gHb, B: 1.99 ± 0.49 µmol/gHb, C: 2.86 ± 0.53 µmol/gHb). Hemolysis levels were increased in group A compared to group B but comparable to the DEHP-free system (A: 0.24 ± 0.06 %, B: 0.21 ± 0.05 %, C: 0.27 ± 0.10 %). However, no single value exceeded 0.8 % even at day 50. Other parameters, including leucocytes, MCV, pH and Hb, demonstrated only minor differences between the groups. The measured PLT characteristics were unaffected by the bag material.

Some differences in RBC parameters were observed between the three combinations of additive solutions and plasticizer types used in the BBS. However, the values of all groups complied with the requirements of the German guidelines even on day 50 after collection. In order to conclusively assess the quality of blood products stored in DEHP-free BBS, it is essential to examine irradiated products and RBCs that are not being mixed during storage due to sampling.

This study was supported by Fresenius Kabi (supply with blood bag samples).