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Use of Recombinant Activated Factor VII (Novoseven) in Trauma and Surgery: Analysis of Outcomes Reported to an International Registry

Anaesthesia and Intensive Care Medicine, St George's Hospital, Tooting, London, UK

Caroline Seebach, MD, PhD

Department of Traumatology, Johann Wolfgang Goethe University, Frankfurt am Main

Christoph Knothe, MD, PhD

Anaesthesiology & Intensive Care, Klinikum Rosenheim, Germany

Piotr Paluszkiewicz, MD, PhD

Department of General Surgery, St Johns Hospital, University Medical School, Lublin, Poland

Terry S. Smith, MD

Department of Critical Care Medicine, Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, Canada

Eduard Kasal, MD, PhD

Anaesthesia & Intensive Department, Charles University Hospital, Alej Svobody, Czech Republic

Ramon Lecumberri, MD, PhD

Hematology Service, University Clinic of Navarra, Pamplona, Spain

Rene Urbanec, MD

Department of Resuscitation and Anaesthesia, Ostrava Faculty Hospital, Poruba, Czech Republic

Thorsten Haas, MD

Department of Anaesthesiology and Critical Care Medicine, Innsbruck, Austria

Maria Wujtewicz, MD, PhD

Department of Anaesthesiology and Intensive Therapy, Medical University Gdask, Gdask, Poland

Dagmar Rehorkova, MD

Department of Anaesthesiology & Critical Care Medicine, Traumatological Hospital Brno, Brno, Czech Republic

Martina Pelichovska, MD

ICU Clinic of Anaesthesia & Resusitation, 2nd Medical Faculty Hospital Motol, Prague, Czech Republic

Martina Lange, MD

R. Elle Hospitasl, Eisenberg, Germany

Maite Uranga, MD

Haematology Service, Hospital Donosti, Donosti-San Sebastian, Spain

Roman Bosman, MD

Charles Teaching Hospital, Lochodin, Czech Republic

J. Hans Rommes, MD, PhD

Department of Intensive Care, Apeldoorn

Juergen Koscielny, MD

Institute for Transfusion Medicine, Charité Humboldt University, Campus Charité Mitte, Berlin, Germany

The objective was to evaluate the efficacy and safety of recombinant activated factor VII in patients with massive bleeding. Forty-five patients with severe massive hemorrhage requiring= 14 transfusion units of packed red blood cells received recombinant activated factor VII. Postdrug blood loss and transfusion requirements were assessed, and mortality was compared with predicted outcomes. Blood loss was markedly reduced in 40 of 43 (93.0%) patients, and transfusion requirements decreased after recombinant activated factor VII administration. Mortality rate in trauma patients who had massive hemorrhage was significantly reduced compared with predictions using scoring systems. This may be associated with the use of recombinant activated factor VII. This study failed to demonstrate an improvement in surgical patients. The absence of concurrent controls prevents definitive conclusions regarding actual safety or efficacy of recombinant activated factor VII.

Key Words: recombinant activated factor VII • NovoSeven • bleeding • trauma • surgery • hemostasis

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Journal of Intensive Care Medicine, Vol. 21, No. 1, 27-39 (2006)
DOI: 10.1177/0885066605285024


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