Summary
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 β-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.
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References
Barker LF, Maynard JE, Purcell RH, Hoofnagle JH, Berquist KR, London WT, Gerety RJ, Krushak DH (1975) Hepatitis B virus infection in chimpanzees: titration of subtypes. J Infect Dis 132: 451–458
Gerety RJ, Aronson DL (1982) Plasma derivatives and viral hepatitis. Transfusion 22: 347–351
Heimburger N, Schwinn H, Gratz P, Luben G, Kumpe G, Herchenhan B (1981) Faktor VIII-Konzentrat, hochgereinigt und in Lösung erhitzt. Arzneimittelforsch 31: 619–622
Heimburger N, Schwinn H, Mauler R, (1980) Faktor VIII-Konzentrat — hepatitissicher: Fortschritte in der Behandlung der Hämophilie A. Gelbe Hefte XX: 165–174
Heinrich D, Kotitschke R, Berthold H (1982) Clinical evaluation of the hepatitis safety of a β-propiolactone/ultraviolet treated factor IX concentrate (PPSB). Thromb Res 28: 75–83
Hoppe I, Maaß H, (1982) Hepatitisrisiko von konventionellen PPSB-Poolpräparaten. Dtsch Med Wochensch 107: 1966–1968
LoGrippo GA, Hartmann FW, (1958) Chemical and combined methods for plasma sterilization. Bibl Haematol 7: 225–230
LoGrippo GA, Hayashi H, (1973) Efficacy of betaprone with ultraviolet irradiation on hepatitis B antigen in human plasma pools. A restrospective study. Henry Ford Hosp Med Bull 21: 181–186
Ohlmeier H, Dahmen E, Hoppe I, (1978) Hepatitisrisiko von humanen Gerinnungspräparaten aus gepoolten Plasmen. Ergebnisse einer Prospektivstudie. Dtsch Med Wochenschr 103: 1700–1703
Prince AM, Stephan W, Brotman B, van den Ende MC (1980) Evaluation of the effect of betapropiolactone/ultraviolet irradiation (βPL/UV) treatment of source plasma on hepatitis transmission by factor IX complex in chimpanzees. Thromb. Haemostasis 44: 138–142
Stephan W (1971) Hepatitis-free and stable human serum for intravenous therapy. Vox Sang 20: 422–457
Stephan W, Berthold H, Prince AM (1981) Effect of combined treatment of serum containing hepatitis B virus with betapropiolactone and ultraviolet irradiation. Vox Sang 41: 134–128
Tabor E, Gerety RJ (1981) The chimpanzee animal model for non-A, non-B hepatitis: new applications. In: Viral hepatitis: 1981 international symposion Franklin, Philadelphia
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Hoppe, I. Hepatitis safety of a new prothrombin complex preparation, sterilized according to the method of LoGrippo. Blut 50, 363–368 (1985). https://doi.org/10.1007/BF00320930
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DOI: https://doi.org/10.1007/BF00320930