Fibrinogen concentrate for perioperative bleeding: what can we learn from the clinical trials?

There is great variation in the study design of the 21 major randomized controlled trials assessing fibrinogen concentrate use in perioperative settings, thus making it a confusing landscape to draw definitive conclusions about the efficacy of this drug. Approximately 60% of the studies in which fibrinogen concentrate was used to treat clinically relevant bleeding showed decreased bleeding tendency and decreased transfusion requirements versus comparative treatment. It is unclear why the remainder did not show decreased bleeding. It should be noted that many patients in these studies 1) did not have significant hypofibrinogemia, 2) did not have significant bleeding in either arm, and/or 3) were treated only once with the intervention during complex major surgeries that required many transfusions. Randomized controlled trials have cumulatively evaluated over 700 patients who received fibrinogen concentrate but have not reported an increase in the rate of perioperative thrombosis in the fibrinogen versus comparator arms.