Human thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues.
In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line . Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride .
Human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.
In combination with fibrinogen, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
Rush Oak Park Hospital, Oak Park, Illinois, United States
North Universitary Hospital, Amiens, France
Charles Nicolle Universitary Hospital, Rouen, France
Nycomed Investigational Site, Bellevue, Washington, United States
Medical University of Vienna, Vienna, Austria
Ruhr University Bochum, Bochum, Germany
Hospital for Special Surgery, New York, New York, United States
Universitätsklinik für Chirurgie, Medizinische Universität Graz, Graz, Austria
Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Berlin, Germany
Klinikum Großhadern, Ludwig-Maximilians-Universität, München, Germany
University Hospital Ghent, Ghent, Belgium
UZ gasthuisberg Leuven, Leuven, Belgium
Investigational site, Dartford, Kent, United Kingdom
Union Memorial Hospital, Baltimore, Maryland, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Northwest NeuroSpecialists, PPLC, Tucson, Arizona, United States
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