1139: FOUR-FACTOR PROTHROMBIN COMPLEX CONCENTRATE FOR REFRACTORY BLEEDING IN TRAUMA AND CARDIAC SURGERY

Abstract

Introduction: Four-Factor Prothrombin Complex Concentrate (4F-PCC) is a concentrated product containing factors II, VII, IX, X, proteins C and S, that is FDA approved for reversal of vitamin K antagonists in adults with acute major bleeding or need for urgent surgery. The utilization of factor products for off-label indications has been increasing secondary to continued national blood shortages and ease of administration, with the hope of reducing blood product utilization. Methods: This single-center retrospective study at an academic level I trauma center analyzed the use of 4F-PCC for refractory bleeding between June 2018 and March 2022 in adult trauma and cardiovascular surgery patients. The primary objective was to determine blood product utilization in patients during a time period of six hours pre and post 4F-PCC administration. Secondary outcomes included thrombotic events, mortality, and use of supportive hemostatic medications. Results: Thirty-five patients received 4F-PCC for significant exsanguination refractory to massive transfusion: cardiac (n=32, 91%) and trauma surgery (n=3, 9%). The median age was 62 years (IQR 50-69) and the majority were male (n=21, 60%). The median dose administered was 2128 units (IQR 1668-2750) or 25 units/kg of factor IX (IQR 20.7-29). Units of blood products given pre and post 4F-PCC administration were: packed red blood cells (PRBC) [5.4 (IQR 3.2-8.9), 2.1 (IQR 1.8-4.1) p< 0.01], fresh frozen plasma (FFP) [4.4 (IQR 2.5-8.0), 3.4 (IQR 1.3-4.7) p=0.03], platelets [1.9 (IQR 1.1-2.2), 1.2 (IQR 1.0-2.2) p=0.20] and cryoprecipitate [1.3 (IQR 0.8-2.4), 0.9 (IQR 0.8-1.8) p=0.83]. Five patients experienced thrombotic events and the mortality was 29%. Three patients received concomitant phytonadione and seven received desmopressin. Conclusions: There was a significant reduction in PRBC and FFP units transfused after 4F-PCC administration in patients for refractory bleeding for trauma and cardiac surgery patients. Further investigation is warranted to determine if the reduction in product administration results in differences in clinical outcomes and if this finding is replicated in other surgical populations.