clinicaltrials.gov Identifier: NCT00563303.

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Introduction:Several series of patient studies have been published on the use of rFVIIa in traumatic haemorrhagic shock, although to date no international recommendations have been produced. France does not currently recognise traumatic haemorrhagic shock as an appropriate indication for the use of rFVIIa.Materials and methods:In this retrospective study, we present our experience in the use of rFVIIa in traumatic haemorrhagic shock.Results:Twenty-seven patients treated with rFVIIa after a traumatic injury between May 2005 and December 2008 were included. Average age was 46 years old. Eighty per cent of patients were polytransfused. Mortality rate was 33%. Adjusted mortality rate, using the Boffard study criteria, was 8.3%. We observed significant differences between the group of patients who died and the group of survivors in pH, PT, Hb, ionised calcaemia, temperature and platelet count. We observed significant differences between the successful rFVIIa group and the failed rFVIIa group in pH, Hb, platelet count and ionised calcaemia. Ten patients had an rFVIIa injection only and 17 patients had an rFVIIa injection combined with a mechanical procedure to stop the bleeding. Two patients presented with thromboembolic complications. We observed a tendency to recommend an rFVIIa injection before radical treatment is applied.Conclusion:It seems to us legitimate to recommend earlier use of rFVIIa in cases of traumatic haemorrhagic shock in the context of haematological damage control combined with the use of an algorithm to predict the risk involved in polytransfusion and a more aggressive transfusion strategy.