Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials

Arch Surg. 2008 Mar;143(3):296-304; discussion 304. doi: 10.1001/archsurg.2007.66.


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 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.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Blood Loss, Surgical / prevention & control*
  • Blood Transfusion
  • Coagulants
  • Cost-Benefit Analysis
  • Factor VIIa / economics
  • Factor VIIa / therapeutic use*
  • Hemostatics / economics
  • Hemostatics / therapeutic use*
  • Humans
  • Perioperative Care
  • Randomized Controlled Trials as Topic
  • Recombinant Proteins / economics
  • Recombinant Proteins / therapeutic use
  • Surgical Procedures, Operative
  • Treatment Outcome


  • Coagulants
  • Hemostatics
  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa