J-F Payen1,2,3, M Berthet4, C Genty5,6, P Declety4, D Garrigue-Huet7, N Morel8, P Bouzat4,2,3, B Riou9,10, J-L Bosson5,6. 1. Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000, Grenoble, France JFPayen@chu-grenoble.fr. 2. INSERM, U1216, F-38000 Grenoble, France. 3. Univ. Grenoble Alpes, Grenoble Institut des Neurosciences, GIN, F-38000 Grenoble, France. 4. Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000, Grenoble, France. 5. Clinical Research Centre, INSERM 003, CHU Grenoble Alpes, F-38000, Grenoble, France. 6. Univ. Grenoble Alpes, CNRS-TIMC-IMAG UMR, 5525-ThEMAS, F-38000 Grenoble, France. 7. Pôle Anesthésie Réanimation, CHU de Lille, F-59037, Lille, France. 8. Pôle Urgences SAMU SMUR, Groupe Hospitalier Pellegrin, CHU de Bordeaux, F-33076, Bordeaux, France. 9. Service d'accueil des Urgences, CHU Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, F-75651, Paris, France. 10. Sorbonne Universités, UPMC Univ. Paris 6, UMRS INSERM 1166, IHU ICAN, Paris, France.
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 109 l-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-1 rFVIIa (82-200) (median, 25th-75th percentile) 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.
BACKGROUND: Management of traumapatients 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 109 l-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-1 rFVIIa (82-200) (median, 25th-75th percentile) 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 traumapatients, meeting guideline criteria before considering rFVIIa was associated with lower mortality and a higher proportion of responders to the rFVIIa.
Authors: Drew Provan; Donald M Arnold; James B Bussel; Beng H Chong; Nichola Cooper; Terry Gernsheimer; Waleed Ghanima; Bertrand Godeau; Tomás José González-López; John Grainger; Ming Hou; Caroline Kruse; Vickie McDonald; Marc Michel; Adrian C Newland; Sue Pavord; Francesco Rodeghiero; Marie Scully; Yoshiaki Tomiyama; Raymond S Wong; Francesco Zaja; David J Kuter Journal: Blood Adv Date: 2019-11-26
Authors: Patrick M Honore; Sebastien Redant; Thierry Preseau; Sofie Moorthamers; Keitiane Kaefer; Leonel Barreto Gutierrez; Rachid Attou; Andrea Gallerani; Willem Boer; David De Bels Journal: Crit Care Date: 2021-11-01 Impact factor: 9.097