Hepatitisrisiko von humanen Gerinnungspräparaten aus gepoolten Plasmen

Abstract

In 1975/76 the risk of hepatitis from human clotting preparations (fibrinogen, prothrombin complex) prepared from pooled plasma was studied prospectively in patients who had undergone open-heart surgery with cardiopulmonary bypass. Of 247 patients 25 (10%) developed hepatitis postoperatively, while of 17 recipients of plasma-fraction concentrates 12 developed hepatitis (71%). Even taking into account other potential risk factors this rate of hepatitis is statistically significant. It demonstrates that even with the most modern screening methods it is not possible to produce clotting preparations from "large pool" human plasma which is free of hepatitis risk, unless additional virus-inactivating measures are taken.

Evaluation of the Effect of Betapropiolactone/Ultraviolet Irradiation (BPL/UV) Treatment of Source Plasma on Hepatitis Transmission by Factor IX Complex in Chimpanzees

“…Eight (8) wild caught juvenile chimpanzees held in the Primate Laboratory, Vilab π, at The Liberian Institute for Biomedical Research, Robertsfield, Liberia, were used Jor this study. The animals ranged in weight from 10.1 to 21.1 kilos (X ≈ 13.6 ± 3.8).…”

“…of 71% in cardiac surgery patients who had received coagulation factor concentrates prepared from plasma which had been screened for hepatitis B surface antigen (HBsAg) by third generation methods (8). In this connection it must be borne in mind that plasma which is negative by radioimmunoassay for HBsAg may still contain up to 10 4 infectious particles per ml of hepatitis B virus (9).…”

Gezielte Hämotherapie

“…Die Risiken sind aber infolge Lagerung undVollständigkeit der Untersuchungsergebnisse deutlich geringer als bei Frischblut. Gegenüber gep~olten~erinnungspräparaten zeich-net es sich durch das niedrigere Hepatitisrisiko (55), den Gehalt von Faktor V, der Inhibitoren sowie der Kininogene aus (2,47). Die Herstellung ist einfach.…”

Prothrombin Complex Concentrates for Clinical Use

“…With the introduction of a sensi tive third-generation assay, the majority of infectious donations are eliminated [138]. The risk can be further reduced by the use of non-remunerated donations [4,63], How ever, under the present circumstances the risk cannot be completely ruled out unless other virus-inactivating measures are devel oped [112], This can be explained partially on the basis of the fact that the infectivity limit in chimpanzees is about IO4-105 times lower than the detection limit of the most sensitive assay for HBsAg marker currently available. Thus, in spite of rigorous screen ing, the majority of large plasma pools may still be contaminated and PCC prepared from such pools will be potentially hazar dous.…”