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Utilisation du facteur VII recombinant activé pour contrôler le saignement en chirurgie cardiaque : études cliniques observationnelles et études expérimentales

Abstract : Background: Bleeding in cardiovascular surgery is a non exceptional complication with significant consequences. Recombinant activated factor VII (rFVIIa) is a powerful haemostatic agent of off-label use in non hemophiliac patients. Prospective randomized controlled trial is difficult to conduce in critical situations. Animal models allow relevant experimentation of such situations. Material and method: In this work we have collected works regarding the use of rFVIIa in: the prospective national registry of French practices in cardiac surgery from 2005 to 2007 and experimentations applied to an original rabbit model of acute arterial bleed. Results: In the registry, rFVIIa was associated with bleed control (stop 43 %, decrease 37 % ongoing bleed 20 %) and a better 28 day survival (60 %) among the 109 patients. In this study, the dose of rFVIIa was around 80 µg/kg. No major thrombotic event was found, noteworthy among the 37 patients with assisting devices (no thrombosis of the system). In non coagulopathic and normothermic rabbits, rFVIIa versus control could promote the sealing of an arterial wound at the doses of 80 and 200 µg/kg with no evidence of local or disseminated thrombosis. Conclusion: In dramatic situations of massive bleed with vital risk and after appropriate blood product compensation, rFVIIa rescue therapy can be performed with a seemingly acceptable safety at a dose around 80 µg/kg
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Marion Durand. Utilisation du facteur VII recombinant activé pour contrôler le saignement en chirurgie cardiaque : études cliniques observationnelles et études expérimentales. Médecine humaine et pathologie. Université Henri Poincaré - Nancy 1, 2010. Français. ⟨NNT : 2010NAN10079⟩. ⟨tel-01746337⟩

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