Abstract

INTRODUCTION: Cirrhotic patients (pts) are at increased risk for bleeding due to alterations in hemostasis. Fresh frozen plasma (FFP) is the most common agent used for reversal of coagulopathy. However, four-factor prothrombin complex concentrate (4F-PCC) usage has increased as it has a lower infusion volume and shorter administration time. The objective of this study was to evaluate the efficacy of 4F-PCC compared to FFP in correcting INR for treatment and prophylaxis of bleeding in pts with cirrhosis undergoing urgent procedures. METHODS: A retrospective chart review of cirrhotic pts who received at least one dose of 4F-PCC or FFP during the defined study period of January 2016 through March 2019 was performed. Pts were identified in the Allscripts EMR. Cirrhosis was identified by the presence of one or more of seven pre-determined diagnostic codes. Pts were excluded if they received both agents within 24 hours or had no documented INRs. Data collected included: age, sex, race, etiology of liver disease, baseline anticoagulant and antiplatelet use, reversal agent administered, baseline and subsequent INR values,, thromboembolic events, mortality, and length of stay (LOS). All data was recorded confidentially and de-identified. The primary outcome was time to INR reversal, defined as an INR of less than 1.5 ULN. Secondary outcomes included thromboembolic event occurrence, all-cause mortality and hospital length of stay. Appropriate statistical analysis was performed. RESULTS: 39 pts were included in the study with 43 reversal agents administered, 29 FFP and 14 4F-PCC. There was no statistical difference in baseline characteristics between groups. A majority of pts had Child’s C cirrhosis. Reversal of INR was observed in 4 FFP pts (14%), and 8 4F-PCC pts (57%). The median time to reversal in the 4F-PCC group was 267.5 minutes (P = 0.035). The reduction in INR from baseline to nadir was 0.5 units (20.5%) in the FFP group and 1.2 units (44%) in the 4F-PCC group (P < 0.001). There was no observed thromboembolic events and mortality rates did not differ between groups (44% vs 30%, P = 0.70). Mean hospital (LOS) was 20.7 days in the FFP group and 12.8 days in the 4F-PCC group (P = 0.67). CONCLUSION: 4F-PCC was associated with significantly 1) improved time to INR reversal, 2)improved extent of INR correction and 3)decreased hospital LOS compared to FFP. Cirrhotic pts with an abnormal INR who present with bleeding may benefit from the administration of 4F-PCC prior to procedural intervention.

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