BACKGROUND:Recombinant factor VIIa (rFVIIa) is used for treatment of bleeding episodes in hemophilia patients who develop inhibitors to factors VIII and IX. We tested the hypothesis that administration of rFVIIa early after injury would decrease bleeding and improve survival after experimental hepatic trauma. METHODS: Anesthetized swine were cannulated for blood sampling and hemodynamic monitoring. Avulsion of left median lobe of the liver induced uncontrolled hemorrhage. After a 10% reduction of mean arterial pressure, animals were blindly randomized to receive intravenous rFVIIa (180 microg/kg) (n = 6) or placebo (n = 7). RESULTS:Mortality was 43% (three of seven) in controls versus 0% with rFVIIa (p = 0.08, chi2). Significantly shorter prothrombin time and higher mean arterial pressures were observed in the rFVIIa group. CONCLUSION: Intravenous administration of rFVIIa early after induction of hemorrhage shortens prothrombin time and improves mean arterial pressure. A trend toward improved survival was observed.
RCT Entities:
BACKGROUND: Recombinant factor VIIa (rFVIIa) is used for treatment of bleeding episodes in hemophiliapatients who develop inhibitors to factors VIII and IX. We tested the hypothesis that administration of rFVIIa early after injury would decrease bleeding and improve survival after experimental hepatic trauma. METHODS: Anesthetized swine were cannulated for blood sampling and hemodynamic monitoring. Avulsion of left median lobe of the liver induced uncontrolled hemorrhage. After a 10% reduction of mean arterial pressure, animals were blindly randomized to receive intravenous rFVIIa (180 microg/kg) (n = 6) or placebo (n = 7). RESULTS: Mortality was 43% (three of seven) in controls versus 0% with rFVIIa (p = 0.08, chi2). Significantly shorter prothrombin time and higher mean arterial pressures were observed in the rFVIIa group. CONCLUSION: Intravenous administration of rFVIIa early after induction of hemorrhage shortens prothrombin time and improves mean arterial pressure. A trend toward improved survival was observed.
Authors: John B Holcomb; Neil R McMullin; Lisa Pearse; Jim Caruso; Charles E Wade; Lynne Oetjen-Gerdes; Howard R Champion; Mimi Lawnick; Warner Farr; Sam Rodriguez; Frank K Butler Journal: Ann Surg Date: 2007-06 Impact factor: 12.969