The Clinical Use of Dried Fibrinogen (Human) and the Risk of Transmitting Hepatitis by Its Administration

Fibrinogen was prepared from large pools of plasma by the method of McCall et al.,21 irradiated with ultraviolet light and distributed on a nationwide basis. Evidence is presented supporting the safety and effectiveness of this fibrinogen product as a decisive factor in the saving of a number of lives. Hepatitis follow-ups were reported for 452 patients who received 1,001 units of fibrinogen plus 2,759 pints of whole blood. Pregnant women comprised 81 per cent of the recipients and probably were more susceptible to hepatitis than the average recipient of whole blood alone. A small group of patients (58) received fibrinogen alone and one hepatitis case resulted (1.7%). A much larger group of patients (394) received large amounts of whole blood (average 7.0 units) along with the fibrinogen and 34 cases of hepatitis developed within the six-month follow-up period. A strikingly long incubation period for the hepatitis cases suggested an effect of pooled gamma globulin (in the fibrinogen product) on the hepatitis virus sufficient to modify its ability to infect man. Significantly, unlike other reported studies, a high hepatitis risk rate was not observed for any single lot.