Recombinant factor VIa (rFVIIa) and its use in severe bleeding in surgery and trauma: a review

Haemorrhage is a potential complication of any surgical procedure, presenting a major challenge to the surgeon and anaesthetist. In addition, uncontrolled bleeding accounts for at least 40% of the mortality associated with military and civilian trauma. Despite the widespread availability of standard interventions for the control of bleeding in such circumstances, there still remains an urgent need for an effective haemostatic agent that is safe, easy to use, and able to enhance local thrombotic processes without causing generalised arterial or venous thrombosis. Recombinant factor VIIa (rFVIIa; NovoSeven(R)) has been successfully used in the management of haemophilia patients with inhibitors for many years. This review will explore its use in the control of surgery- and trauma-associated haemorrhage in patients without pre-existing coagulopathy, and will highlight the growing realisation that rFVIIa may have a major role not only as a treatment for haemophilia, but also as a universal haemostatic agent. This paper will also briefly explore those unanswered questions that should be resolved by future trials aiming to further clarify the safety, efficacy, and optimal dosing strategies of rFVIIa in the surgical and trauma settings. (C) 2003 Elsevier Science Ltd. All rights reserved.