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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 von Heymann C; Jonas S; Spies C; Wernecke KD; Ziemer S; Janssen D; Koscielny JCrit Care 2008[]; 12 (1): R14BACKGROUND: 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. CONCLUSION: 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.|Abdomen/surgery[MESH]|Cardiovascular Surgical Procedures[MESH]|Factor VIIa/adverse effects/*therapeutic use[MESH]|Female[MESH]|Humans[MESH]|Intraoperative Complications/*drug therapy[MESH]|Male[MESH]|Postoperative Hemorrhage/drug therapy/mortality/*prevention & control[MESH]|Recombinant Proteins/adverse effects/therapeutic use[MESH]|Thromboembolism/chemically induced[MESH]|Urologic Diseases/surgery[MESH] |
