Analysis and results of the recombinant factor VIIa extended-use registry.
This paper describes the analysis of recombinant factor VIIa (rFVIIa; NovoSeven; Novo Nordisk, Bagsvaerd, Denmark) use in 40 patients with intractable bleeding in the UK. All cases were reported on the 'rFVIIa extended use database' (Traumanet) between its launch in February 1999 and 12 March 2002. Twenty-one other cases reporting rFVIIa use in different circumstances were excluded from the analysis. Recombinant FVIIa was effective in stopping or markedly reducing blood loss in 80% of patients; 20% of patients did not respond to treatment. Non-responders tended to have more deranged coagulation and lower platelet counts compared with responders. Despite a wide range of underlying illnesses, including malignancy and sepsis, few patients suffered adverse events. Thrombotic events occurred in three of 40 (7.5%) patients and these patients were considered as already at risk of thrombosis from other causes. The data suggest that rFVIIa is safe and effective therapy in patients with uncontrollable haemorrhage.
The Department of Haematology, Faculty of Medicine, Imperial College, Hammersmith Hospital W12 0NN, UK. M.laffan@ic.ac.uk
Michael
M
Laffan
Niamh M
NM
O'Connell
David J
DJ
Perry
Andrew J
AJ
Hodgson
Denise
D
O'Shaughnessy
Owen P
OP
Smith
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D015897:Comorbidity; D005167:Factor VII / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy* / Q000453:epidemiology; D006490:Hemostatics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007494:Ireland / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012042:Registries / Q000706:statistics & numerical data; D012449:Safety; D019851:Thrombophilia / Q000150:complications; D013927:Thrombosis / Q000139:chemically induced / Q000209:etiology; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
D000933:Antifibrinolytic Agents; D006490:Hemostatics; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa