From the Literature

 

Published: Oct 2019

Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: The FIBRES randomized clinical trial.
Callum J, Farkouh ME, Scales DC, et al.
JAMA 2019; Oct 21 [Epub ahead of print].
Pub Med
NATA rating :

 

REVIEW by:
D. Faraoni

 

NATA REVIEW:
Hypofibrinogenaemia is frequently observed in bleeding patients after cardiac surgery with cardiopulmonary bypass. In case of excessive bleeding and acquired hypofibrinogenaemia, the most recent guidelines recommend the administration of either cryoprecipitate or fibrinogen concentrate. Although cryoprecipitate remains the treatment of choice is some countries (e.g. Canada, United States), cryoprecipitate is not longer available in several other countries. So far, very few studies have directly compared those two options in bleeding patients undergoing cardiac surgery.

The FIBRES randomised clinical trial is a large multicentre study in patients undergoing cardiac surgery requiring fibrinogen replacement because of significant bleeding and hypofibrinogenaemia (defined as a plasma fibrinogen <2.0 g/L by the Clauss method or FIBTEM measured at 10 min <10 mm). The objective of the study was to determine if fibrinogen concentrate was non-inferior to cryoprecipitate as measured by allogeneic blood requirements.

Of 827 randomised patients, 372 received fibrinogen concentrate and 363 received cryoprecipitate. Mean 24-hour post-bypass allogeneic transfusions were 16.3 units in the fibrinogen group and 17.0 units in the cryoprecipitate group. Thromboembolic events occurred in 26 patients (7%) in the fibrinogen concentrate group and 35 patients (9.6%) in the cryoprecipitate group.

The results of the study are important for several reasons. Firstly, this large randomised controlled study demonstrated that fibrinogen concentrate can be used as an effective alternative to cryoprecipitate in the presence of bleeding and hypofibrinogenaemia in adults undergoing cardiac surgery with cardiopulmonary bypass.

Secondly, as mentioned in the discussion by the authors, cryoprecipitate is a plasma-derived product that presents some risk of pathogen transmission potentially associated with poor outcomes and increased cost. Although the study did not report any differences in clinical outcome, one should remember that the incidence of those events is extremely low and that an unreasonably large number of patients would be needed to report any significant difference.

Last but not least, it is important to keep in mind that the administration of cryoprecipitate does not only supplement with an inconsistent concentration of fibrinogen, but also with other factors that might not be deficient or might increase the risk of thrombotic complications. In this regard, it may be argued that fibrinogen concentrate offers a more predictable and safer profile than cryoprecipitate.

In summary, the results of FIBRES study demonstrate that fibrinogen concentrate is an effective and safe alternative to cryoprecipitate in patients experiencing excessive bleeding in the presence of hypofibrinogenaemia in the perioperative period of cardiac surgery.


– David Faraoni