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  • Efficacy and Safety of Reco...
    Mayer, Stephan A; Brun, Nikolai C; Begtrup, Kamilla; Broderick, Joseph; Davis, Stephen; Diringer, Michael N; Skolnick, Brett E; Steiner, Thorsten

    The New England journal of medicine, 05/2008, Letnik: 358, Številka: 20
    Journal Article

    In a previous phase 2 placebo-controlled trial, recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and functional outcome in patients with intracerebral hemorrhage. Those findings were not reproduced in this phase 3 trial, in which rFVIIa reduced hematoma growth but did not improve clinical outcomes. In this phase 3 trial, recombinant activated factor VII (rFVIIa) reduced hematoma growth but did not improve clinical outcomes in patients with intracerebral hemorrhage. Intracerebral hemorrhage is the most devastating form of stroke. Approximately 40% of patients with intracerebral hemorrhage die within 30 days, and the majority of survivors are left with severe disability. 1 , 2 Hematoma growth occurs in up to 70% of patients who have intracerebral hemorrhage documented by computed tomographic (CT) scanning performed within 3 hours after the onset of symptoms. 3 , 4 Furthermore, hemorrhage expansion is an independent determinant of death and disability. 4 In addition to intracerebral-hemorrhage growth, other predictors of poor outcome include age, baseline volume of the hemorrhage, Glasgow Coma Scale score, intraventricular hemorrhage, and infratentorial location. 5 There is no . . .