Challenging Bleeders - A Symposium for Haemostasis Specialists: Proceedings of the Edinburgh Haematology Symposium; November 8-9 2002, Edinburgh, UK: ReviewAnalysis and results of the recombinant factor VIIa extended-use registryLaffan, Michaela; O'Connell, Niamh M.b; Perry, David J.b; Hodgson, Andrew J.c; O'Shaughnessy, Denised; Smith, Owen P.cSection Editor(s): Ludlam, Christopher Author Information aThe Department of Haematology, Faculty of Medicine, Imperial College, Hammersmith Hospital W12 0NN, UK, bThe Katharine Dormandy Haemophilia Centre and Haemostasis Unit, The Royal Free Hospital, Pond Street, London NW3 2QG, UK, cNational Centre for Hereditary Coagulation Disorders, St. James's Hospital, Dublin 8, Ireland and dSouthampton General Hospital, SO16 6YD, UK. Correspondence and requests for reprints to Dr Mike Laffan, 4th Floor Commonwealth Building, Hammersmith Hospital, Ducane Road, London, W12 0HS, UK. Tel: +44 (0)208 383 2178; e-mail: M.email@example.com Blood Coagulation & Fibrinolysis: June 2003 - Volume 14 - Issue - p S35-S38 Buy Abstract 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. © 2003 Lippincott Williams & Wilkins, Inc.