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

@article{citeulike:3151710, abstract = {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.}, address = {Department of Cardiovascular Anaesthesia, IRCCS Policlinico S. Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy. cardioanestesia@virgilio.it}, author = {Ranucci, M. and Isgr\`{o}, G. and Soro, G. and Conti, D. and De Toffol, B.}, citeulike-article-id = {3151710}, citeulike-linkout-0 = {http://dx.doi.org/10.1001/archsurg.2007.66}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/18347278}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=18347278}, doi = {10.1001/archsurg.2007.66}, issn = {1538-3644}, journal = {Archives of surgery (Chicago, Ill. : 1960)}, keywords = {factor7}, month = {March}, number = {3}, posted-at = {2008-08-24 01:31:58}, priority = {2}, title = {Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials.}, url = {http://dx.doi.org/10.1001/archsurg.2007.66}, volume = {143}, year = {2008} }

TY - JOUR ID - citeulike:3151710 L3 - citeulike-article-id:3151710 N2 - 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. IS - 3 JF - Archives of surgery (Chicago, Ill. : 1960) SN - 1538-3644 AD - Department of Cardiovascular Anaesthesia, IRCCS Policlinico S. Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy. cardioanestesia@virgilio.it TI - Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials. VL - 143 KW - factor7 AU - Ranucci, M AU - Isgrò, G AU - Soro, G AU - Conti, D AU - De Toffol, B PY - 2008/03// UR - http://dx.doi.org/10.1001/archsurg.2007.66 ER -