[Hepatitis risk of human plasma-fraction concentrates of pooled plasma (author's transl)]

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.