www.ccmjournal.org Critical Care Medicine • Volume 46 • Number 1 (Supplement) Learning Objectives: Off-label medication use is common in critically ill patients in the United States. Kcentra® is a 4-factor… Click to show full abstract
www.ccmjournal.org Critical Care Medicine • Volume 46 • Number 1 (Supplement) Learning Objectives: Off-label medication use is common in critically ill patients in the United States. Kcentra® is a 4-factor prothrombin complex concentrate (4PCC) approved for warfarin reversal in patients with acute major bleeding or need for urgent surgery. As with other procoagulants, non-approved use occurs. However, there is a paucity of data describing the real-life utilization of 4PCC. The aim of this snapshot analysis is to characterize the FDA approved and non-approved uses of 4PCC in 5 medical centers over a specified period of time. Methods: This multi-center retrospective analysis of 4PCC use in critically ill patients occurred from January 1, 2016 through December 31, 2016. All adult ICU patients who received 4PCC at a participating center were eligible for inclusion. Data included: demographics, 4PCC dose, coagulation parameters before and after 4PCC administration, blood product and hemostatic agent administration as well as incidence of thromboembolic events (TEEs). Results: A total of 104 patients from 5 institutions were included. Anticoagulant use prior to 4PCC was present in 80 patients (76.9%), and 63 (78.8%) were warfarin. The type of bleeding includes: intracranial (n = 33), trauma (n = 23), cardiac surgery (n = 12), GI (n = 12), musculoskeletal (n = 2), other (n = 13). The mean 4PCC dose was 30 IU/kg. The median INR prior to and 12–24 hours following 4PCC was 2.2 and 1.5, respectively. Fortyeight patients (46.2%) received off-label 4PCC which included: massive hemorrhage on novel oral anticoagulants (29.2%), cardiac surgery (25%), acute coagulopathy (20.8%), non-cardiac surgery (10.4%), or other (14.6%). Of 92 patients, excellent and good hemostatic efficacy was achieved in 21 and 49 patients, respectively. Of the patients who achieved excellent hemostatic efficacy, 15 received 4PCC on-label and 6 received 4PCC off-label (p < 0.05). There were 11 TEEs. Conclusions: Although the predominant use of 4PCC was on label, many patients received offlabel 4PCC during the index study period. Further study is needed to identify the relative clinical impact, risk and cost associated with real-life utilization of 4PCC.
               
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