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.

STUDY DESIGN AND 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: Johan W Lagerberg, Eric Gouwerok, Richard Vlaar, Mya Go, Dirk de Korte
• Journal: Transfusion (Transfusion) Vol. 55 Issue 3 Pg. 522-31 (Mar 2015) ISSN: 1537-2995 [Electronic] United States
• PMID: 25331824 (Publication Type: Comparative Study, Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 AABB.

Chemical References

• ADSOL
• AS-3 preservative solution
• Citrates
• Cyclohexanecarboxylic Acids
• Dicarboxylic Acids
• PAGGS-M solution
• Pharmaceutical Solutions
• Phosphates
• Plasticizers
• diisononyl 1,2-cyclohexanedicarboxylic acid
• Guanosine
• Mannitol
• Sodium Chloride
• Diethylhexyl Phthalate
• Glucose
• Adenine

Topics

• Adenine (pharmacology)
• Blood Cells (cytology, drug effects)
• Blood Coagulation (drug effects)
• Blood Preservation (instrumentation)
• Blood Specimen Collection (instrumentation)
• Citrates (pharmacology)
• Cryopreservation (instrumentation)
• Cyclohexanecarboxylic Acids
• Dicarboxylic Acids
• Diethylhexyl Phthalate (blood)
• Glucose (pharmacology)
• Guanosine (pharmacology)
• Hemolysis (drug effects)
• Humans
• In Vitro Techniques
• Leukocyte Reduction Procedures
• Mannitol (pharmacology)
• Pharmaceutical Solutions (pharmacology)
• Phosphates (pharmacology)
• Plasticizers (analysis)
• Sodium Chloride (pharmacology)
• Time Factors