Recombinant activated factor VII as a universal haemostatic agent.

Haemostasis is initiated by the complex formed by tissue factor (TF) and activated factor VII (FVIIa) present in the blood [1% of the factor VII (FVII) protein]. Recombinant FVIIa (rFVIIa), enzymatically active only after complex formation with TF exposed following tissue damage, has been demonstrated to induce haemostasis in haemophilia patients with life- and limb-threatening bleedings with an efficacy rate of 76-84% in patients having failed on other treatment. rFVIIa has been successfully used in patients with congenital FVII deficiency and has been demonstrated to normalize the prolonged prothrombin time in patients with liver disease and in warfarin-treated individuals. In patients with thrombocytopenia, rFVIIa shortened the prolonged bleeding time in 50% of the patients treated and a haemostatic effect on acute bleeds in eight patients was demonstrated. One patient with Glanzmann's thrombasthenia and three with Type III von Willebrand's disease were successfully treated with rFVIIa. By exploiting the binding capacity of FVIIa to platelets, rFVIIa, may also be used to enhance normal haemostasis in patients without coagulation defects but suffering from bleedings in organs or at sites with limited possibilities for mechanical haemostasis.