Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials.
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.
Ranucci
Marco
M
Department of Cardiovascular Anaesthesia, IRCCS Policlinico S. Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy. cardioanestesia@virgilio.it
Isgrò
Giuseppe
G
Soro
Giorgio
G
Conti
Daniela
D
De Toffol
Barbara
B
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
D003029:Coagulants; D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa