title: Are quality differences responsible for different adverse reactions reported for SD-plasma from USA and Europe?
abstract: Thromboembolic adverse reactions reported after transfusion of SD-plasma in the United States (US) prompted us to perform a comparative study with SD-plasma from the US and the European (EU) market. In SD-plasma from US, residual tri-N-butyl phosphate was found, and citrate concentrations were lower than in EU-plasma. Except for substantial losses of FV, FVIII and antiplasmin found for all SD-plasmas, clotting factor activities were mainly retained. However, for SD-plasma from US, markedly elevated concentrations of lipoprotein (a) [Lp(a)], fibrin monomer and a particularly high degree of complement activation (C3a des-Arg) were observed. Furthermore, pronounced differences were found for protein S. Although SD-plasma pools from US contained nearly normal concentrations of free and bound protein S antigen, protein S activities were almost completely absent. In contrast to this, SD-plasma from EU showed a moderate loss of both protein S activity and free antigen. Antitrypsin inhibitor activities were much more diminished in SD-plasma from US than from EU. In view of a possible thrombogenicity of SD-plasma from US, the loss of protein S and elevated Lp(a) concentrations could be of significance. The very high levels of C3a des-Arg in US plasma could possibly have an additional effect, through priming platelet activation after transfusion.
authors.affiliation: Paul-Ehrlich-Institut, Langen, Germany. salur@pei.de
authors.forename: U
authors.initials: U
authors.lastname: Salge-Bartels
authors.forename: S
authors.initials: S
authors.lastname: Breitner-Ruddock
authors.forename: A
authors.initials: A
authors.lastname: Hunfeld
authors.forename: R
authors.initials: R
authors.lastname: Seitz
authors.forename: M
authors.initials: M
authors.lastname: Heiden
mesh_terms: D001779:Blood Coagulation Factors / Q000032:analysis; D015926:Complement C3a / Q000032:analysis; D005060:Europe; D005337:Fibrin / Q000032:analysis; D006801:Humans; D017270:Lipoprotein(a) / Q000032:analysis; D010949:Plasma / Q000737:chemistry; D010951:Plasma Exchange / Q000009:adverse effects* / Q000592:standards*; D017293:Protein S / Q000032:analysis; D013923:Thromboembolism / Q000209:etiology; D014481:United States
chemical_list: D001779:Blood Coagulation Factors; D017270:Lipoprotein(a); D017293:Protein S; D015926:Complement C3a; D005337:Fibrin