In vitro evaluation of di(2-ethylhexyl)terephthalate-plasticized polyvinyl chloride blood bags for red blood cell storage in AS-1 and PAGGSM additive solutions.

BACKGROUND

Di(2-ethylhexyl)phthalate (DEHP) makes polyvinyl chloride flexible for use in blood bags and stabilizes the red blood cell (RBC) membrane preventing excessive hemolysis. DEHP migrates into the blood product and rodent studies have suggested that DEHP exposure may be associated with adverse health effects albeit at high dosages. Although structurally and functionally similar to DEHP, di(2-ethylhexyl)terephthalate (DEHT; or Eastman 168 SG [Eastman Chemical Company]) is metabolically distinct with a comprehensive and benign toxicology profile. This study evaluated RBC stability in DEHT-plasticized bags with AS-1 and PAGGSM compared to conventional DEHP-plasticized bags with AS-1.

STUDY DESIGN AND METHODS

Thirty-six whole blood units were collected into CPD solution, leukoreduced, centrifuged, and divided into RBCs and plasma. To limit donor-related variability, three ABO-identical RBCs were mixed together and then divided equally and stored among the three different plasticizer and additive solution combinations. RBCs from 12 trios were analyzed for a standard panel of in vitro variables on Day 0 and after storage.

RESULTS

No individual bag on Day 42 exceeded the US 1.0% hemolysis criteria. While hemolysis during storage was higher in the DEHT bags, the PAGGSM RBCs were close to the control RBCs (0.38% vs. 0.32%, respectively). ATP retention was higher than 70% and potassium levels were similar regardless of plasticizer. Additional RBC variables exhibited some significant differences but were not viewed as clinically important.

CONCLUSION

DEHT/PAGGSM provides similar hemolysis protection to that of DEHP/AS-1. Although hemolysis values with DEHT and AS-1 are higher than that of DEHP, DEHT is a potential DEHP alternative.