Efficacy and Safety of Fibrinogen Concentrate in Surgical Patients: A Meta-Analysis of Randomized Controlled Trials

Objectives To investigate the efficacy and safety of fibrinogen concentrate (FC) in surgical patients. Design Meta-analysis of randomized controlled studies (RCTs). Setting Perioperative. Participants Adult and pediatric surgical patients. Interventions A search of PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, Transfusion Evidence Library, Google Scholar, and the proceedings from major international anesthesiology meetings up to February 1, 2016 for RCTs that compared FC with placebo or other comparators. Measurements and Main Results The primary outcome was all-cause mortality. Pooled risk ratios and mean differences (MDs) were computed with either fixed-effects or random-effects models. The study included 14 RCTs comprising 1,035 patients; the majority of patients underwent cardiac surgery. All-cause mortality was lower in the fibrinogen group (4/432 [0.9%] v 15/430 [3.5%]; risk ratio 0.26; 95% confidence interval [CI] 0.09-0.78; p = 0.02; heterogeneity statistic (l2) = 0%). The use of FC was associated with reduced bleeding (MD –127 mL; 95% CI –207 to –47; p = 0.002; I2= 54%) and a lower number of red blood cells units transfused versus comparator (MD –0.9; 95% CI –1.3 to –0.5; p<0.001; I2 = 42%). There were no differences in the rates of thrombotic events and myocardial infarction. Conclusions In surgical patients, FC was associated with reduced bleeding and a lower number of red blood cell units transfused, and it also might reduce mortality. However, none of the analyzed trials was powered for estimation of survival and adverse events with FC use. Half of the included studies were of high or moderate risk of bias. The evidence primarily came from cardiac surgery settings.