tion of the agent of homologous serum hepatitis. Trans¬ fusion of pooled dried plasma, even though irradiated, I 1 Patients Investigated 1 Patients with Hepatitis B Deaths IO 20 33 38 38 AGE BY DECADE 24 26 12 Incidence of hepatitis and deaths by age groups.involves a calculated risk that should be considered care¬ fully in relation to the need of the patient for this thera¬ peutic agent.
SUMMARY AND CONCLUSIONSFour hundred and sixty-four records of patients who had received pooled, dried irradiated human plasma 150 or more days previously were investigated. The records of 180 patients were found adequate to warrant a study of the occurrence of serum hepatitis as a result of the plasma transfusion. Twenty-three or 12.8% of the 180 patients had signs and symptoms of serum hepatitis. Seven or 30.5% had died as a direct result of the disease or a combination of their original disease and the hepa¬ titis. Of 64 patients who had received only plasma and no whole blood, 6(9.3%) had hepatitis. The occurrence of a 12.8% incidence of hepatitis is considered signifi¬ cantly higher than that of hepatitis as the result of blood transfusion alone (0.5% ) or the incidence of infectious hepatitis (0.02% ). The findings indicate that the meth¬ ods now used for the irradiation of pooled plasma in large-scale production are not wholly effective in com¬ plete destruction of the agent of homologous serum hepatitis.7. Henle, G.; Drake, M. E.; Henle, W.Pooled human plasma, untreated, has been a frequent cause of serum hepatitis. Blood from one donor carrying the virus can make a whole pool infectious. Obviously the likelihood of plasma being infected varies with the number of donors making up the pool. Plasma from a large pool is more frequently infected than plasma from a small pool. The probability of contracting serum hepatitis from a whole blood transfusion is extremely small. Paine and Janeway1 have analyzed reports on this subject.Exposing plasma to ultraviolet light seemed to obviate this hazard. Known icterogenic serum so treated has been given in small quantities to volunteers without causing hepatitis.2 MacCallum,3 on the other hand, used a different technique of irradiation that failed to prevent the transmission of hepatitis. Irradiation of plasma has been required by the National Institutes of Health since April, 1949, as a prerequisite to licensing manufacturers.That irradiation does not always inactivate the virus was shown by James, Korns, and Wright4 who reported the occurrence of 12 cases of serum hepatitis among 20 recipients of one lot of irradiated plasma. Of course this outbreak could have been due to faulty irradiation of the plasma involved, rather than to the inefficacy of ir¬ radiation as a means of inactivating hepatitis virus. There have been other reports 5 attributing serum hepatitis to irradiated plasma, but this apparent association could have been coincidental rather than causal. To pursue this problem further, a series of patients who received irradiated plasma from several sources was studied to dete...