Haemorrhagic complications of thrombocytopenia and oral anticoagulation: is there a role for recombinant activated factor VII?

Recombinant activated factor VII (rFVIIa, 'NovoSeven') is indicated for the treatment of bleeding in patients with haemophilia and inhibitors to factors VIII or IX. However, by virtue of its ability to promote thrombin generation on the platelet surface rFVIIa may also be effective in non-haemophilic bleeding, for example, in patients with thrombocytopenic or oral anticoagulant-induced haemorrhage. Studies in thrombocytopenia indicate that rFVIIa increases the generation of thrombin at the site of injury, leading to the control of bleeding episodes in these conditions. Additionally, preclinical and early clinical evidence has demonstrated the ability of rFVIIa to normalise prothrombin times and international normalised ratios in situations of over-anticoagulation. Although initial observations indicate that rFVIIa may be fast, efficacious, and safe in reversing oral anticoagulant-induced bleeds and those associated with thrombocytopenia, randomised, double-blind, placebo-controlled trials must be conducted to confirm its utility in these and other investigational uses.