title: In vitro evaluation of the quality of blood products collected and stored in systems completely free of di(2-ethylhexyl)phthalate-plasticized materials.
abstract: BACKGROUND
  The plasticizer di(2-ethylhexyl)phthalate (DEHP) is a common component in blood bags. DEHP is noncovalently bound to polyvinylchloride (PVC) polymer and can leach into the blood product. There are public concerns that exposure to DEHP might induce developmental and reproductive toxicity in humans. The aim of this study was to evaluate an alternative plasticizer, di(isononyl) cyclohexane-1,2-dicarboxylate (Hexamoll DINCH, BASF SE), for its use in blood bags.
  
  
  METHODS
  Whole blood (WB) was collected into DEHP-containing and DEHP-free collection systems. After overnight hold, WB was centrifuged and separated in plasma, buffy coat, and red blood cells (RBCs). Buffy coats and plasma were used to make platelet (PLT) concentrates in DEHP-free systems. After addition of additive solution (AS), SAG-M, PAGGS-M, AS-3, or PAGGG-M, RBCs were leukoreduced and analyzed for in vitro characteristics and plasticizer levels during storage.
  
  
  RESULTS
  The use of DINCH-based systems had no effect on WB composition, blood processing, and plasma quality. PLT in vitro quality variables were maintained during storage in DEHP-free systems. During storage in SAG-M, hemolysis was significantly higher in DINCH-PVC while potassium leakage and adenosine triphosphate content were comparable. During storage in alternative ASs, hemolysis was reduced compared to storage in SAG-M.
  
  
  CONCLUSIONS
  The complete absence of DEHP in the collection system had no effect on WB composition, processing, or plasma and PLT quality. During storage in SAG-M, the absence of DEHP resulted in increased hemolysis. With alternative ASs like PAGGS-M, AS-3, or PAGGG-M, the absence of DEHP had no effect on hemolysis. Leakage of DINCH into the blood product was less pronounced than that of DEHP.
authors.affiliation: Blood Cell Research, Sanquin Research, Amsterdam, the Netherlands.
authors.forename: Johan W
authors.initials: JW
authors.lastname: Lagerberg
authors.forename: Eric
authors.initials: E
authors.lastname: Gouwerok
authors.forename: Richard
authors.initials: R
authors.lastname: Vlaar
authors.forename: Mya
authors.initials: M
authors.lastname: Go
authors.forename: Dirk
authors.initials: D
authors.lastname: de Korte
mesh_terms: D000225:Adenine / Q000494:pharmacology; D001773:Blood Cells / Q000166:cytology / Q000187:drug effects; D001777:Blood Coagulation / Q000187:drug effects; D001793:Blood Preservation / Q000295:instrumentation*; D001800:Blood Specimen Collection / Q000295:instrumentation*; D002951:Citrates / Q000494:pharmacology; D015925:Cryopreservation / Q000295:instrumentation; D003509:Cyclohexanecarboxylic Acids; D003998:Dicarboxylic Acids; D004051:Diethylhexyl Phthalate / Q000097:blood; D005947:Glucose / Q000494:pharmacology; D006151:Guanosine / Q000494:pharmacology; D006461:Hemolysis / Q000187:drug effects; D006801:Humans; D066298:In Vitro Techniques; D047589:Leukocyte Reduction Procedures; D008353:Mannitol / Q000494:pharmacology; D019999:Pharmaceutical Solutions / Q000494:pharmacology; D010710:Phosphates / Q000494:pharmacology; D010968:Plasticizers / Q000032:analysis; D012965:Sodium Chloride / Q000494:pharmacology; D013997:Time Factors
chemical_list: C037839:ADSOL; C058647:AS-3 preservative solution; D002951:Citrates; D003509:Cyclohexanecarboxylic Acids; D003998:Dicarboxylic Acids; C430585:PAGGS-M solution; D019999:Pharmaceutical Solutions; D010710:Phosphates; D010968:Plasticizers; C558012:diisononyl 1,2-cyclohexanedicarboxylic acid; D006151:Guanosine; D008353:Mannitol; D012965:Sodium Chloride; D004051:Diethylhexyl Phthalate; D005947:Glucose; D000225:Adenine