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  • Title: Off-label use of recombinant activated factor VII in intractable haemorrhage after cardiovascular surgery: an observational study of practices in 23 French cardiac centres (2005-7).
    Author: Hacquard M, Durand M, Lecompte T, Boini S, Briançon S, Carteaux JP.
    Journal: Eur J Cardiothorac Surg; 2011 Dec; 40(6):1320-7. PubMed ID: 21550261.
    Abstract:
    OBJECTIVES: The study aimed to describe French off-label use of rFVIIa for intractable bleeding in major cardiovascular surgery. METHODS: Retrospective observational analysis of data from 2005 to October 2007 (no formal guidelines were available) was employed. The collect request form was elaborated by a multidisciplinary committee. RESULTS: Data on 109 patients--37 mechanical cardiac assist devices--were collected, with repeated injection for 24%. Bleeding stopped, decreased or continued in 43%, 37% and 20% of the cases, respectively. For patients treated in the intensive care unit (ICU), hourly bleeding decreased from 365 ± 212 to 115 ± 106 ml h(-1) (p<0.001). The median number of transfused products was 25 (2-90) before and 6 (0-48) after rFVIIa (p<0.001). Most patients had been well compensated with fibrinogen (>1g.l(-1)) and platelets (>50 G.l(-1)) before rFVIIa. The bleeding outcome (cessation, decrease or no change) was associated with the infused dose (81 ± 31, 71 ± 24, 64 ± 23 μg.kg(-1); p = 0.044) and did not differ whether rFVIIa was administered in the operating room (49%) or ICU (51%). Thrombotic events occurred in 13% of patients without assist devices and in 27% of those with them (but without obvious intra-device clotting). The overall 28-day survival rate was 60% and associated with bleeding outcome (p = 0.002). CONCLUSIONS: rFVIIa rescue therapy was followed by control of bleeding in a substantial number of the patients with seemingly acceptable safety; however, thrombotic risk remains a matter of concern. Our observational study suggests that the dose to be tested prospectively is at least 80 μg.kg(-1).
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