Recombinant activated factor VII in the treatment of intractable non-surgical bleeding following major vascular procedures

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A recombinant form of activated factor VII (rFVIIa) is a haemostatic drug that is approved for use in haemophiliacs with antibodies to factor VIII or factor IX. Most recent studies and clinical experience have shown that rFVIIa (NovoSeven, Novo Nordisk A/S, Denmark) gives extreme haemostatic effect in patients with severe "non-haemophilic" bleeding produced after trauma and major surgery. We present our preliminary experience of the use of rFVIIa in vascular surgery when conventional haemostatic measures are inadequate. There were 32 patients divided into five groups: Group I--14 patients with ruptured abdominal aortic aneurysms; Group II--10 patients with thoracoabdominal aortic aneurysms; Group III--5 patients with retroperitoneal tumours involving great abdominal vessels; Group IV--2 patients with portal hypertension and Group V--one patient with iatrogenic injury of brachial artery and vein during fibrinolytic treatment, because of myocardial infarction. Clinical improvement was detected following treatment in 29 patients. Bleeding was successfully controlled as evidenced by improved haemodynamic parameters and decreased inotropic and transfusion requirements. In vascular patients more liberal use of rFVlla is limited, because no randomized controlled trial has proved its efficacy and safety in such patients; while also keeping in mind that the price of a 4.8 mg of rFVIIa is $4080. We recommend the use of rFVIIa in vascular surgery only during and after operative treatment of thoracoabdominal aortic aneurysms, ruptured abdominal aortic aneurysms, retroperitoneal tumours involving the aorta and/or inferior vena cava, as well as portal hypertension, when non-surgical massive uncontrolled bleeding are present.