Recombinant activated factor VIIa for the treatment of bleeding in major abdominal surgery including vascular and urological surgery: a review and meta-analysis of published data
1 Department of Anesthesiology and Intensive Care Medicine, Charité-University Medicine Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Augustenburger Platz 1, 13353 Berlin, Germany
2 Department of General and Transplantation Surgery, Charité-University Medicine Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany
3 Sophisticated Statistical Analysis (SOSTANA) GmbH, Berlin, Wildensteiner Str. 27, 10318 Berlin, Germany
4 Institute of Laboratory Medicine and Pathological Biochemistry, Charité-University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany
5 Med-i-Scene Concept GmbH, Schlesierstr. 9, 91085 Weisendorf, Germany
6 Institute of Transfusion Medicine, Charité-University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany
Critical Care 2008, 12:R14 doi:10.1186/cc6788Published: 15 February 2008
The purpose of this study was to determine the role of recombinant activated factor VII (rFVIIa) in abdominal, vascular, and urological surgery.
We conducted meta-analyses of case series and placebo-controlled studies reporting on the treatment or prophylaxis of bleeding with rFVIIa regarding 'reduction or cessation of bleeding', 'mortality', and 'thromboembolism'.
All case reports (n = 15 case reports and 17 patients) documented an effect of rFVIIa in the treatment of bleeding. A meta-analysis of 10 case series revealed a reduction or cessation of bleeding in 39 out of 50 patients after administration of rFVIIa (estimated mean effect 73.2%, 95% confidence interval [CI] 51.0% to 95.4%) and a mean probability of survival of 53.0% (95% CI 26.4% to 79.7%). Among the rFVIIa responders, 19 out of 29 patients (66%) survived versus 1 out of 10 rFVIIa nonresponders (P = 0.003). Six out of 36 patients from the case series had a thromboembolic complication (estimated mean probability 16.5%, 95% CI 1.2% to 31.8%). Compared with a meta-analysis of eight placebo-controlled studies, no increased risk of thromboembolism was seen after administration of rFVIIa.
The meta-analysis of case series showed that, in a mean of 73% patients, rFVIIa achieved at least a reduction of bleeding and that the probability of survival is increased in patients responding to rFVIIa. rFVIIa was not associated with an increased risk of thromboembolism compared with placebo.