Solvent/detergent-treated plasma: composition, efficacy, and safety.
OBJECTIVE
Recent reports on adverse events associated with solvent/detergent-treated plasma have raised concerns about the efficacy and safety of this type of therapeutic plasma. Comparisons of various brands of solvent/detergent-treated plasma have revealed substantial differences in their composition.


RESULTS
Retrospective analyses and case reports suggest an association between the low protein S activity levels found in solvent/detergent-treated plasma and venous thromboembolism when solvent/detergent-treated plasma is given for thrombotic thrombocytopenic purpura or transfused massively during liver transplantation surgery. Augmented bleeding caused by hyperfibrinolysis, possibly caused by the low plasmin inhibitor (also termed alpha2-antiplasmin) activity of solvent/detergent-treated plasma, has also been a matter of concern. The efficacy and safety of various types of solvent/detergent-treated plasma have been studied intensively for all indications for therapeutic plasma by at least five prospective trials, four observational studies, and post-licensure monitoring. A review of the literature shows that the clinical significance of transient protein S and plasmin inhibitor deficiency has been considerably overstated, even when such deficiency might be aggravated by the administration of large amounts of solvent/detergent-treated plasma. However, different brands of solvent/detergent-treated plasma differ substantially with respect to their composition and hemostatic balance. It cannot be completely excluded that the very low citrate and protein S concentrations versus higher clotting factor concentrations found in a given brand of solvent/detergent-treated plasma could contribute to coagulation activation in the settings of thrombotic thrombocytopenic purpura and liver transplantation.


CONCLUSIONS
Future research should seek to optimize the composition of solvent/detergent-treated plasma. Prospective trials and prospective hemovigilance studies are required to determine the rate of adverse events occurring after treatment with solvent/detergent-treated plasma and other types of therapeutic plasma.
Hellstern
Peter
P
Institute of Hemostaseology and Transfusion Medicine, Academic City Hospital, Ludwigshafen, Germany. peterhellstern@medicusnet.de
D016913:Blood Component Transfusion / Q000009:adverse effects*; D003902:Detergents / Q000494:pharmacology*; D006801:Humans; D016031:Liver Transplantation / Q000009:adverse effects / Q000379:methods; D010949:Plasma / Q000187:drug effects; D011697:Purpura, Thrombotic Thrombocytopenic / Q000150:complications / Q000628:therapy; D012997:Solvents / Q000494:pharmacology*
D003902:Detergents; D012997:Solvents