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Methods: We conducted a single center retrospective comparison of patients who received PCC before versus after implementing a fixed-dose protocol. The protocol limited PCC doses to 1000 or 1500 units for all indications except intracranial hemorrhage. Adult patients who received PCC were eligible for inclusion except those who received PCC for organ transplant surgery. The primary outcome was a failure composite of effectiveness and safety (failed hemostasis, need for additional reversal agents, or failure to meet INR goal if used for procedural reversal; or thrombosis within 3 days, respectively). Secondary outcomes included initial and total PCC dose, INR goal attainment, absolute and percent change in INR, ICU and hospital length of stay (LOS), all-cause hospital mortality, and additional reversal agent use within 48 hours of PCC administration.

Results: Baseline characteristics were similar between the …