Biomaterial Database

Clinical evaluation of the hepatitis safety of a beta-propiolactone/ultraviolet treated factor IX concentrate (PPSB). 1982

D Heinrich, and R Kotitschke, and H Berthold

The association of viral hepatitis, type B, with the use of prothrombin complex concentrates (PPSB) has been well documented. PPSB prepared from cold-sterilized plasma (beta-propiolactone treated and UV irradiated) has been shown not to induce hepatitis in chimpanzees. 500 U of cold-sterilized PPSB were infused into 5 healthy male volunteers. Previous to, and up to 6 months after, PPSB-application in addition to careful clinical investigations, the following hepatitis parameters were determined: SGOT, SGPT, y-GT, alkaline phosphatase, total serum bilirubin, HBsAg, HBcAb and HBsAb. On the basis of all of the above parameters there was no indication of induction of viral hepatitis following the application of PPSB prepared from beta-propiolactone/UV treated plasma.

UI	MeSH Term	Description	Entries
D007783	Lactones	Cyclic esters of hydroxy carboxylic acids, containing a 1-oxacycloalkan-2-one structure. Large cyclic lactones of over a dozen atoms are MACROLIDES.	Lactone
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D011420	Propiolactone	Disinfectant used in vapor form to sterilize vaccines, grafts, etc. The vapor is very irritating and the liquid form is carcinogenic.	Propanolide,beta-Propiolactone,beta Propiolactone
D011516	Prothrombin	A plasma protein that is the inactive precursor of thrombin. It is converted to thrombin by a prothrombin activator complex consisting of factor Xa, factor V, phospholipid, and calcium ions. Deficiency of prothrombin leads to hypoprothrombinemia.	Coagulation Factor II,Factor II,Blood Coagulation Factor II,Differentiation Reversal Factor,Factor II, Coagulation,Factor, Differentiation Reversal,II, Coagulation Factor
D003080	Cold Temperature	An absence of warmth or heat or a temperature notably below an accustomed norm.	Cold,Cold Temperatures,Temperature, Cold,Temperatures, Cold
D005164	Factor IX	Storage-stable blood coagulation factor acting in the intrinsic pathway of blood coagulation. Its activated form, IXa, forms a complex with factor VIII and calcium on platelet factor 3 to activate factor X to Xa. Deficiency of factor IX results in HEMOPHILIA B (Christmas Disease).	Autoprothrombin II,Christmas Factor,Coagulation Factor IX,Plasma Thromboplastin Component,Blood Coagulation Factor IX,Factor 9,Factor IX Complex,Factor IX Fraction,Factor Nine,Factor IX, Coagulation
D006509	Hepatitis B	INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.	Hepatitis B Virus Infection
D006514	Hepatitis B Surface Antigens	Those hepatitis B antigens found on the surface of the Dane particle and on the 20 nm spherical and tubular particles. Several subspecificities of the surface antigen are known. These were formerly called the Australia antigen.	Australia Antigen,HBsAg,Hepatitis B Surface Antigen,Antigen, Australia
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man