title: Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery.
abstract: BACKGROUND
  Most recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate.
  
  
  METHODS
  There were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa.
  
  
  RESULTS
  Postoperative blood loss was significantly lower in group N treated with rFVII (P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, (P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C (P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C (P < .0001).
  
  
  CONCLUSIONS
  Our findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients.
authors.affiliation: Clinic for Vascular and Endovascular Surgery, Serbian Clinical Center, 8 K. Todorovica St, Belgrade 11000, Republic of Serbia. dr.koncar@gmail.com
authors.forename: Igor B
authors.initials: IB
authors.lastname: Končar
authors.forename: Lazar B
authors.initials: LB
authors.lastname: Davidović
authors.forename: Nebojsa
authors.initials: N
authors.lastname: Savić
authors.forename: Radomir B
authors.initials: RB
authors.lastname: Sinđelić
authors.forename: Nikola
authors.initials: N
authors.lastname: Ilić
authors.forename: Marko
authors.initials: M
authors.lastname: Dragas
authors.forename: Miroslav
authors.initials: M
authors.lastname: Markovic
authors.forename: Dusan
authors.initials: D
authors.lastname: Kostic
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D017544:Aortic Aneurysm, Abdominal / Q000150:complications / Q000401:mortality / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000209:etiology / Q000401:mortality / Q000601:surgery*; D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control*; D016009:Chi-Square Distribution; D017707:Erythrocyte Transfusion; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D017713:Platelet Transfusion; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D055771:Serbia; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000009:adverse effects* / Q000401:mortality
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa