I designed and conducted a survey to obtain baseline information on blood component use in relation to clinical diagnosis. A total of 79 hospitals, all of which employ a computerized management system for transfusion, participated in this survey.
Transfusion records of 219, 967 units were collected from 8, 704 patients. Of these units, platelets, fresh frozen plasma (FFP) and red blood cells (RBCs) accounted for 51%, 27% and 22%, respectively. Among the high RBCs uses, heart and great vessel conditions accounted for 16.4%, and malignant diseases of the blood for 16.3%. 64.3% of platelet use was in malignancy of the blood and high usage of FFP was seen in malignancy of the liver, biliary tract and pancreas (22.9%) and cancer of the digestive tract (16%). It is interesting to note that the heart and great vessel conditions also showed high usage of both platelets and FFP. The use of directed donor blood remains rare and that of autologous blood is observed mainly in orthopedic applications, which accounted for less than 5% of total RBC use.
This survey provides the first report on therapeutic applications for blood components in Japanese hospitals. The number of transfusions and types of blood components were clarified. This report will benefit the management of blood banking programs and facilitate the appropriate use of blood components for transfusions.

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The possibility of the transmission of HIV-1 by non-heated Factor-VIII and Factor-IX preparations has made it urgent to confirm the safety of our non-heated fibrinogen preparation with respect to the possibility of HIV-1 transmission. Fortunately, no cases of HIV-1 transmission by our former non-heated fibrinogen preparation have been reported. We studied potentially effective steps for HIV-1 inactivation or elimination in the manufacturing process for the former non-heated fibrinogen preparation. Using HIV-1 spiking, four steps were studied: cryoprecipitation, 8% ethanol fractionation, 6.5% ethanol washing and ultraviolet (UV) irradiation. MT-4 or human H9 cells were used for HIV-1 assay. Process samples (cryoprecipitate-rich plasma, cryoprecipitate-poor plasma, fibrinogen solution etc.) and 1/10 volume of HIV-1 solution were mixed and then processed under manufacturing conditions.
The cryoprecipitation step did not reduce HIV-1 infectivity. HIV-1 was inactivated by the 8% ethanol fractionation step. This inactivation was confirmed by two independent laboratories (>3.0log, experiment 1, and >5.0log, experiment 2). The two 6.5% ethanol washing steps each inactivated HIV-1 (2.6log). UV irradiation of the fibrinogen preparation at one Joule/ml inactivated HIV-1 (1.1-1.2log). The total reduction and clearance factors for all process steps combined were >6.7 and >12.3log, respectively.
Since these validation tests were performed under worst case conditions for both the ethanol fractionation steps (short incubation time, lower ethanol concentration) and UV irradiation (higher protein concentration), we expect greater reduction and clearance factors in actual production.

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