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.
Key Words
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Article info
Publication history
Published online: August 01, 2016
Identification
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© 2016 Elsevier Inc. All rights reserved.
