Abstract
Background and AimIntraoperative blood loss is a frequent complication of hepatic resection and orthotopic liver transplantation. Recombinant activated coagulation factor VII (rFVIIa) is a coagulation protein that induces hemostasis by directly activating factor X. There is no clear information about the prophylactic value of rFVIIa in hepatobiliary surgery, specifically in liver resection and orthotopic liver transplantation. The aim of this study was to assess the effect of rFVIIa prophylaxis to prevent mortality and bleeding resulting from hepatobiliary surgery.MethodsRelevant randomized trials were identified by searching The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index. Randomized clinical trials comparing different rFVIIa prophylactic schemas against placebo or no intervention to prevent bleeding in hepatobiliary surgery were included. Adults undergoing liver resection, partial hepatectomy, or orthotopic liver transplantation were included. Dichotomous data were analyzed calculating odds ratios (ORs) and 95% confidence intervals (CIs). Continuous data were analyzed calculating mean differences (MD) and 95% CIs.ResultsFour randomized controlled trials were included. There were no significant differences between rFVIIa and placebo for mortality (OR 0.96; 95% CI 0.35–2.62), red blood cell units (MD 0.32; 95% CI −0.08–0.72) or adverse events (OR 1.55; 95% CI 0.97–2.49).ConclusionsThe available information is limited, precluding the ability to draw conclusions regarding bleeding prophylaxis in hepatobiliary surgery using rFVIIa. Although an apparent lack of effect was observed in all outcomes studied, further research is needed.
Highlights
Hepatic resection is often accompanied by intraoperative blood loss occurring during parenchyma transection or tumor resection
There were no significant differences between rFVIIa and placebo for mortality, red blood cell units (MD 0.32; 95% confidence intervals (CIs) 20.08–0.72) or adverse events
The number of patients included in the trials who underwent partial hepatectomy [3,10] or orthotopic liver transplantation (OLT) [4,11] ranged from 83 to 221
Summary
Hepatic resection is often accompanied by intraoperative blood loss occurring during parenchyma transection or tumor resection. Orthotopic liver transplantation (OLT) may cause excessive blood loss during surgery, which may lead to increased postoperative morbidity and mortality [1]. Pharmacological approaches have been used to induce a primary hemostatic effect in an attempt to reduce intraoperative blood loss [3]. Recombinant activated coagulation factor VII (rFVIIa) (NovoSeven, Novo Nordisk, Denmark) is a coagulation protein that induces hemostasis through direct activation of factor X, starting the conversion of prothrombin to thrombin to form a hemostatic clot. Intraoperative blood loss is a frequent complication of hepatic resection and orthotopic liver transplantation. Recombinant activated coagulation factor VII (rFVIIa) is a coagulation protein that induces hemostasis by directly activating factor X. There is no clear information about the prophylactic value of rFVIIa in hepatobiliary surgery, in liver resection and orthotopic liver transplantation. The aim of this study was to assess the effect of rFVIIa prophylaxis to prevent mortality and bleeding resulting from hepatobiliary surgery
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