title: Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials.
abstract: OBJECTIVE
  To investigate the efficacy and safety of recombinant activated factor VII (rFVIIa) treatment in patients undergoing major surgical procedures.
  
  
  METHODS
  Relevant studies were searched in BioMedCentral, CENTRAL, PubMed, and PubMed Central.
  
  
  METHODS
  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.
  
  
  METHODS
  We followed the Cochrane Collaboration method for data extraction and internal validity procedures, as well as the Quality of Reporting of Meta-analyses statement.
  
  
  RESULTS
  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 mug/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.
authors.affiliation: Department of Cardiovascular Anaesthesia, IRCCS Policlinico S. Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy. cardioanestesia@virgilio.it
authors.forename: Marco
authors.initials: M
authors.lastname: Ranucci
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Isgrò
authors.forename: Giorgio
authors.initials: G
authors.lastname: Soro
authors.forename: Daniela
authors.initials: D
authors.lastname: Conti
authors.forename: Barbara
authors.initials: B
authors.lastname: De Toffol
mesh_terms: D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D003029:Coagulants; D003362:Cost-Benefit Analysis; D015942:Factor VIIa / Q000191:economics / Q000627:therapeutic use*; D006490:Hemostatics / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D019990:Perioperative Care; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D013514:Surgical Procedures, Operative; D016896:Treatment Outcome
chemical_list: D003029:Coagulants; D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa