Recombinant activated factor VII (rFVIIa-NovoSeven^®-NovoNordisk) treatment of bleeding complications in intensive care unit

Recombinant activated factor VII (rFVIIa-NovoSeven^®-Novordisk) was first developed to treat severe bleeding episodes occurring in patients with haemophilia A or B with inhibitor. Complexed with tissue factor, it activates the factor × and allows transformation of prothrombin into thrombin, independently of factors VIII and IX. The success of rFVIIa in controlling haemophilic bleedings has led to use it, punctually for other serious bleedings in liver transplantation, cardiac surgery or in cirrhotic patients.

We report five cases of patients hospitalised in intensive care unit, with haemorrhagic shock or severe haemostasis disorder. Despite of massive transfusions and usual resuscitation therapeutics, their clinical course was pejorative. Then, they were given a 90 μg/kg rFVIIa intravenous dose. See Table 1.

Table 1

A dramatic improvement occurred in a few hours. The majority of haemorrhages stopped after one or two rFVIIa doses administration. The immediate correction of haemostasis disorders allowed a reduction in blood transfusions amount and a decreasing of amine support requiring. One patient presented a thrombosis of the portal venous system quickly corrected, but no other adverse event could be attributed to rFVIIa.

rFVIIa-NovoSeven^® appears to be of great interest in the treatment of uncontrolled haemorrhage in intensive care units. It can be considered as an efficient and safe therapy. Nevertheless, because of its high price and of the very preliminary nature of the data we report, further investigations are necessary before using this product as a routine treatment.