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Systematic Review and Meta-analysis of Randomized Clinical Trials

Marco Ranucci, MD; Giuseppe Isgrò, MD; Giorgio Soro, MD; Daniela Conti, MD; Barbara De Toffol, MD

Arch Surg. 2008;143(3):296-304.

Objective  To investigate the efficacy and safety of recombinant activated factor VII (rFVIIa) treatment in patients undergoing major surgical procedures.

Data Sources  Relevant studies were searched in BioMedCentral, CENTRAL, PubMed, and PubMed Central.

Study Selection  Only randomized controlled trials on humans undergoing major surgery were included. Efficacy was determined as the rate of patients receiving allogeneic packed red blood cells; safety was assessed in terms of thromboembolic complications and mortality rate.

Data Extraction  We followed the Cochrane Collaboration method for data extraction and internal validity procedures, as well as the Quality of Reporting of Meta-analyses statement.

Data Synthesis  Seven randomized controlled trials met the inclusion criteria. Treatment with rFVIIa is associated with a reduced risk of receiving allogeneic packed red blood cells (odds ratio, 0.29; 95% confidence interval, 0.10-0.80). In a subgroup analysis, only patients receiving at least 50 µg/kg of rFVIIa had a significant benefit (odds ratio, 0.43; 95% confidence interval, 0.23-0.78). No differences in thromboembolic complications and mortality rates were observed.

Conclusions  Treatment with rFVIIa is effective in reducing the rate of patients undergoing transfusion with allogeneic packed red blood cells. However, the cost-benefit ratio is favorable only in patients who need a huge number of packed red blood cell units. No safety concerns arise from the present study.

Author Affiliations: Department of Cardiovascular Anaesthesia, IRCCS Policlinico S. Donato, Milan, Italy.

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