Guidelines for the treatment of bleeding due to hypofibrinogenemia (fibrinogen level <1.5-2.0 g/L) after cardiac surgery recommend using either cryoprecipitate or fibrinogen concentrate, but comparative data for the two treatment strategies is lacking. As reported this week at the AABB 2019 Annual Meeting and published in JAMA, the FIBRES randomized non-inferiority clinical trial compared these two products at 11 Canadian hospitals. From February 2017 to November 2018, 735 patients undergoing cardiac surgery with hypofibrinogenemia related bleeding post-surgery were randomized 1:1 to receive either fibrinogen concentrate (N=372, 4 g) or cryoprecipitate (N=362, 10 units). A mean of 16.3 (95% CI, 14.9 to 17.8) units of allogenic blood derived products (red blood cells, platelets, and plasma) were transfused in the 24 hours post-surgery in the fibrinogen concentrate group compared to 17.0 (95% CI, 15.6-18.6) units in the cryoprecipitate group (P<0.001 for non-inferiority; P=0.50 for superiority). Non-inferiority for fibrinogen concentrate was also reported for cumulated allogenic blood components transfused 7 days post-surgery, and adverse events were similar in both groups. Further research and considerations on fibrinogen concentrate vs. cryoprecipitate should focus on other patients with hypofibrinogenemia, cost, and the risk of transfusion-transmitted infections.
References:
- Callum J, Farkouh ME, Scales DC, Heddle NM, et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: the FIBRES randomized clinical trial. JAMA 2019; doi:10.1001/jama.2019.17312
- Callum J, Farkouh ME, Scales DC, Heddle NM, et al. Abstract PL1-MN4-32: The FIBRES randomized controlled noninferiority trial of fibrinogen concentrates versus cryoprecipitate in cardiac surgery: subgroup and safety analysis. Presented at AABB Annual Meeting; 2019 Oct 19-22; San Antonio, TX.