title: Reduced mortality by meeting guideline criteria before using recombinant activated factor VII in severe trauma patients with massive bleeding.
abstract: BACKGROUND
  Management of trauma patients with severe bleeding has led to criteria before considering use of recombinant activated factor VII (rFVIIa), including haemoglobin >8 g dl-1, serum fibrinogen ≥1.0 g l-1, platelets >50,000 x 109l-1, arterial pH ≥ 7.20, and body temperature ≥34 °C. We hypothesized that meeting these criteria is associated with improved outcomes.
  
  
  METHODS
  In this prospective cohort study of 26 French trauma centres, subjects were included if they received rFVIIa for persistent massive bleeding despite appropriate care after severe blunt and/or penetrating trauma.
  
  
  RESULTS
  After surgery and/or embolization as haemostatic interventions, 112 subjects received a first dose of 103 μg kg-1rFVIIa (82-200) (median, 25th-75thpercentile) at 420 min (285-647) post-trauma. Of these, 71 (63%) "responders" were still alive at 24h post-trauma and had their transfusion requirements reduced by > 2 packed red blood cell units after rFVIIa treatment. Mortality was 54% on day 30 post-trauma. There were 21%, 44% and 35% subjects who fulfilled 0-1, 2-3 or 4-5, respectively, of the guidelines before receiving rFVIIa. Survival at day 30 was 13%, 49% and 64% and the proportion of responders was 39%, 64% and 82%, when subjects fulfilled 0-1, 2-3 or 4-5 conditions, respectively (both P <0.01).
  
  
  CONCLUSIONS
  In actively bleeding trauma patients, meeting guideline criteria before considering rFVIIa was associated with lower mortality and a higher proportion of responders to the rFVIIa.
authors.affiliation: Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000, Grenoble, France JFPayen@chu-grenoble.fr.|INSERM, U1216, F-38000 Grenoble, France.|Univ. Grenoble Alpes, Grenoble Institut des Neurosciences, GIN, F-38000 Grenoble, France.
authors.forename: J-F
authors.initials: JF
authors.lastname: Payen
authors.affiliation: Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000, Grenoble, France.
authors.forename: M
authors.initials: M
authors.lastname: Berthet
authors.affiliation: Clinical Research Centre, INSERM 003, CHU Grenoble Alpes, F-38000, Grenoble, France.|Univ. Grenoble Alpes, CNRS-TIMC-IMAG UMR, 5525-ThEMAS, F-38000 Grenoble, France.
authors.forename: C
authors.initials: C
authors.lastname: Genty
authors.affiliation: Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000, Grenoble, France.
authors.forename: P
authors.initials: P
authors.lastname: Declety
authors.affiliation: Pôle Anesthésie Réanimation, CHU de Lille, F-59037, Lille, France.
authors.forename: D
authors.initials: D
authors.lastname: Garrigue-Huet
authors.affiliation: Pôle Urgences SAMU SMUR, Groupe Hospitalier Pellegrin, CHU de Bordeaux, F-33076, Bordeaux, France.
authors.forename: N
authors.initials: N
authors.lastname: Morel
authors.affiliation: Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000, Grenoble, France.|INSERM, U1216, F-38000 Grenoble, France.|Univ. Grenoble Alpes, Grenoble Institut des Neurosciences, GIN, F-38000 Grenoble, France.
authors.forename: P
authors.initials: P
authors.lastname: Bouzat
authors.affiliation: Service d'accueil des Urgences, CHU Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, F-75651, Paris, France.|Sorbonne Universités, UPMC Univ. Paris 6, UMRS INSERM 1166, IHU ICAN, Paris, France.
authors.forename: B
authors.initials: B
authors.lastname: Riou
authors.affiliation: Clinical Research Centre, INSERM 003, CHU Grenoble Alpes, F-38000, Grenoble, France.|Univ. Grenoble Alpes, CNRS-TIMC-IMAG UMR, 5525-ThEMAS, F-38000 Grenoble, France.
authors.forename: J-L
authors.initials: JL
authors.lastname: Bosson
mesh_terms: D000328:Adult; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D019983:Guideline Adherence; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D014947:Wounds and Injuries / Q000401:mortality*
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: factor VIIa; haemorrhage; shock, traumatic