1. The use of fibrinogen concentrate for fibrinogen replacement, post cardiac surgery, is noninferior to cryoprecipitate.
Evidence Rating Level: 1 (Excellent)
Study Rundown: A common postoperative complication with cardiac surgery is excessive bleeding which consequently requires blood component transfusion. The guidelines for the management of cardiac surgery-associated bleeding presenting with acquired hypofibrinogenemia recommend use of either cryoprecipitate or fibrinogen concentrate as treatment options. Despite knowing that cryoprecipitate is a non-purified product, has a limited shelf life, and is more difficult to store and administer when compared to fibrinogen concentrate, it remains the treatment of choice in much of North America. This study evaluated the first 24 hours after cardiopulmonary bypass, to analyze the mean number of blood components transfused. The results demonstrated a lower mean value for the allopathic transfusions of the group receiving the fibrinogen concentrate compared to the cryoprecipitate.
This study successfully randomized a large sample size into the study treatment groups while assuring the baseline variables remained balanced. The study was limited by a lack of blinding of the clinicians to the treatment assignment, however, this did not lead to any differences with the timing of transfusions compared to the administering of the treatment. Furthermore, the outcome collection part of the study was completed by blinding the outcome assessors and the patients to treatment allocation. The adverse events and transfusion data was reviewed independently by monitors which strengthens the findings. Lastly, the study results are not generalizable to all patients receiving fibrinogen replacement therapy, given the study inclusion criteria recruiting strictly patients with excessive bleeding post cardiac surgery.
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