Clinical utilization of four-factor prothrombin complex concentrate: a retrospective single center study

Four-factor prothrombin complex concentrate (4F-PCC) was approved by the US Food and Drug Administration in 2013 for management of severely bleeding patients on warfarin therapy. We describe use of 4F-PCC at a large, suburban academic center.

We retrospectively reviewed all patients receiving 4F-PCC from its introduction through 2016 at a large level 1 trauma center. Clinical and demographic data were obtained, including indications for anticoagulation and antiplatelet agents, comorbidities, concomitant medications, etiology and site of bleeding, as well as disposition, length of stay, mortality, and thrombotic events.

One hundred eighty-four patients received 4F-PCC. Mean age was 72 years; 40.8% were female. Indications for 4F-PCC administration included: active bleeding (74%), reversal prior to a procedure (14%), and elevated international normalized ratio (12%). Warfarin was the most common concomitant medication (71.1%). Most patients were receiving anticoagulation for atrial fibrillation (63%). Concomitant treatments for bleeding included vitamin K (58.2%), packed red blood cells (50%), fresh frozen plasma (38%), and platelets (26.1%), amongst others. Median length of hospital stay was 8.4 days. Nine patients (4.9%) developed thrombosis within 90 days of 4F-PCC. Mortality was 24.5%, with notably higher rates amongst those who received 4F-PCC for off-label indications (19.1% on-label mortality vs. 37.7% off-label mortality on chi-square analysis, P=0.01).

This study demonstrates that 4F-PCC is being utilized for indications other than the reversal of warfarin-induced coagulopathy. Further investigation is warranted to determine the efficacy and safety of 4F-PCC for these potential indications.