Research

Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding – a European perspective

Jean-Louis Vincent¹ , Rolf Rossaint², Bruno Riou³, Yves Ozier⁴, David Zideman⁵ and Donat R Spahn⁶

¹Department of Intensive Care, Erasme Hospital, Free University of Brussels, Route de Lennik 808, 1070 Brussels, Belgium

²Department of Anaesthesiology of the University Hospital, RWTH, Pauwelsstrasse 30, 52074 Aachen, Germany

³Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, 47–83 Boulevard de l'Hôpital, 75651 Paris, France

⁴Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin, Assistance publique-Hôpitaux de Paris, Faculté de Medecine, Paris-V, Université Rene-Descartes, 27 Rue du faubourg Saint-Jacques, 75679 Paris, France

⁵European Resuscitation Council, ERC Secretariat, Universiteitsplein 1, 2610 Antwerp, Belgium

⁶Department of Anaesthesiology, University Hospital Lausanne, Rue du Bugnon 46, 1011 Lausanne, Switzerland

author email corresponding author email

Critical Care 2006, 10:R120doi:10.1186/cc5026

Published:	18 August 2006

Abstract

Introduction

Our aim was to develop consensus guidelines for use of recombinant activated factor VII (rFVIIa) in massive hemorrhage.

Methods

A guidelines committee derived the recommendations using clinical trial and case series data identified through searches of available databases. Guidelines were graded on a scale of A to E (with A being the highest) according to the strength of evidence available. Consensus was sought among the committee members for each recommendation.

Results

A recommendation for the use of rFVIIa in blunt trauma was made (grade B). rFVIIa might also be beneficial in post-partum hemorrhage (grade E), uncontrolled bleeding in surgical patients (grade E), and bleeding after cardiac surgery (grade D). rFVIIa could not be recommended for use in the following: in penetrating trauma (grade B); prophylactically in elective surgery (grade A) or liver surgery (grade B); or in bleeding episodes in patients with Child–Pugh A cirrhosis (grade B). Efficacy of rFVIIa was considered uncertain in bleeding episodes in patients with Child–Pugh B and C cirrhosis (grade C). Monitoring of rFVIIa efficacy should be performed visually and by assessment of transfusion requirements (grade E), while thromboembolic adverse events are a cause for concern. rFVIIa should not be administered to patients considered unsalvageable by the treating medical team.

Conclusion

There is a rationale for using rFVIIa to treat massive bleeding in certain indications, but only adjunctively to the surgical control of bleeding once conventional therapies have failed. Lack of data from randomized, controlled clinical trials, and possible publication bias of the case series data, limits the strength of the recommendations that can be made.