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.
BACKGROUND
The purpose of this study was to determine the role of recombinant activated factor VII (rFVIIa) in abdominal, vascular, and urological surgery.


METHODS
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'.


RESULTS
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.


CONCLUSIONS
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.
von Heymann
Christian
C
Department of Anesthesiology and Intensive Care Medicine, Charité-University Medicine Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Augustenburger Platz 1, 13353 Berlin, Germany. christian.von_heymann@charite.de
Jonas
Sven
S
Spies
Claudia
C
Wernecke
Klaus-Dieter
KD
Ziemer
Sabine
S
Janssen
Detlev
D
Koscielny
Jürgen
J
D000005:Abdomen / Q000601:surgery; D013504:Cardiovascular Surgical Procedures; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000188:drug therapy*; D008297:Male; D019106:Postoperative Hemorrhage / Q000188:drug therapy / Q000401:mortality / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013923:Thromboembolism / Q000139:chemically induced; D014570:Urologic Diseases / Q000601:surgery
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa