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Recombinant factor VIIa (NovoSeven RT) use in high risk cardiac surgery.
AJ Chapman, AL Blount, AT Davis... - European journal of ..., 2011 - Objective: The use of recombinant factor VIIa (r FVIIa) (Novo Seven RT()) to establish hemostasis
during massive perioperative bleeding in cardiac surgery has been explored in several retrospective
studies. While early results are promising, a paucity of data leaves many questions about ...
The use of recombinant factor VI Ia (r FVI Ia) (Novo Seven RT(®)) to establish hemostasis during massive perioperative bleeding in cardiac surgery has been explored in several retrospective studies. While early results are promising, a paucity of data leaves many questions about its safety profile. We sought to further define its use and associated outcomes in a large cohort study at a single institution.
A retrospective cohort study design was used, in which 236 patients received r FVI Ia for bleeding after cardiac surgery. These patients were matched with a cohort of 213 subjects, who had similar operations during the same period of time. Primary end points included thrombo-embolic events, mortality, incidence of re-operation, use of blood products, and patient disposition at 30 days. Statistical significance was assessed at p < 0.05.
There was no statistically significant difference in the incidence of stroke (3.4%, 1.9%; p = 0.32), renal failure (8.5%, 7.0%; p = 0.57), or 30-day mortality (7.7%, 4.3%; p = 0.14) between the r FVI Ia and the control groups, respectively. The r FVI Ia group did experience a higher rate of re-operation for bleeding (11.0%, 1.9%; p = 0.0001) and had a two-fold increase in the use of each of the following: cryoprecipitate, fresh-frozen plasma, platelets, and packed red blood cells, relative to the control group (p < 0.00001).
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Recombinant factor VIIa (NovoSeven RT) use in high risk cardiac surgery. |
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