Recombinant FVIIa in the management of uncontrolled hemorrhage.
BACKGROUND
Recombinant FVIIa (rFVIIa/NovoSeven) is a novel hemostatic agent originally developed to treat patients with hemophilia who had developed inhibitors. Several case reports have suggested that rFVIIa may be effective in treating patients without a pre-existing bleeding disorder who have uncontrolled bleeding.


METHODS
Data on the efficacy and safety of rFVIIa in the treatment of massive hemorrhage were obtained retrospectively from the NovoSeven extended-use data collection system.


RESULTS
A total of 40 patients received rFVIIa for uncontrolled bleeding, and in these patients, bleeding stopped or decreased in 32 (80%). Blood product usage was significantly decreased after rFVIIa administration. Thromboembolic events occurred in three patients with additional risk factors for thrombosis. Of 40 patients, 23 (57.5%) died. Bleeding was the direct cause of death in seven cases (all within 24 hr of administration of rFVIIa). The remaining 16 deaths were the result of sepsis, multi-organ failure, or the underlying disease.


CONCLUSIONS
In this retrospective study of data voluntarily submitted to a web-based drug surveillance program, we present preliminary results on the use of rFVIIa in nonhemophilia patients with bleeding. Although some efficacy is suggested, there was a high mortality rate from nonhemorrhagic causes. Randomized controlled trials are needed to properly assess the role of rFVIIa in the management of hemorrhage.
O'Connell
Niamh M
NM
Katherine Dormandy Hemophilia Center, Royal Free and University College Medical School, London. n.o'connell@rfc.ucl.ac.uk
Perry
David J
DJ
Hodgson
Andrew J
AJ
O'Shaughnessy
Denise F
DF
Laffan
Michael A
MA
Smith
Owen P
OP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000627:therapeutic use; D016913:Blood Component Transfusion; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins; D006470:Hemorrhage / Q000188:drug therapy* / Q000601:surgery; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; D015942:Factor VIIa