Hepatitis safety of a new prothrombin complex preparation, sterilized according to the method of LoGrippo. Results of a prospective clinical trial.

In a controlled, prospective clinical trial with almost 300 patients undergoing cardiovascular surgery, the hepatitis risk was examined of a new prothrombin complex (PPSB) preparation produced from pooled plasma, which was cold sterilized according to the method of LoGrippo with beta-propiolactone and UV-light. Of 268 evaluable patients, 102 belonged to a group receiving PPSB and 166 belonged to a control group without PPSB. 25 batches of PPSB in dosages of up to 4,500 units per patient, in total, were used. The mean requirement for transfusion of blood or plasma was 10 units per patient in the group receiving PPSB and slightly more than 2 units per patient in the control group. In both of the groups, 3 hepatitis infections occurred (5 cases of non-A, non-B, 1 case of type B), corresponding to hepatitis incidences of 2.9 and 1.8%, respectively. The difference in hepatitis incidence between both groups was statistically not significant. This demonstrates, on the one hand, the hepatitis safety of the sterilized PPSB and, on the other, that multiple transfusion is no longer associated with a high risk of hepatitis when the guidelines of modern donor screening are followed.

RCT Entities:   Population Interventions Outcomes