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

Area of Science:

• Hematology
• Pharmacology
• Clinical Medicine

Background:

• Four-factor prothrombin complex concentrate (4F-PCC) received FDA approval in 2013 for managing severe bleeding in warfarin patients.
• Real-world utilization patterns of 4F-PCC in academic centers remain under-documented.

Purpose of the Study:

• To describe the clinical use of 4F-PCC at a large suburban academic center.
• To evaluate indications, patient demographics, and outcomes associated with 4F-PCC administration.

Main Methods:

• Retrospective review of 184 patients who received 4F-PCC from its introduction through 2016.
• Data collection included indications for use, comorbidities, concomitant medications, bleeding characteristics, and patient disposition.
• Outcomes assessed were length of stay, mortality, and thrombotic events.

Main Results:

• The majority of patients (74%) received 4F-PCC for active bleeding, with 14% for procedural reversal and 12% for elevated INR.
• Warfarin was the most common concomitant medication (71.1%), and atrial fibrillation the most frequent indication for anticoagulation (63%).
• Mortality was 24.5%, with significantly higher rates in patients receiving 4F-PCC for off-label indications (37.7%) compared to on-label use (19.1%).

Conclusions:

• 4F-PCC is increasingly used for indications beyond warfarin reversal.
• The study highlights potential safety concerns, particularly higher mortality in off-label use.
• Further research is essential to establish the efficacy and safety profile of 4F-PCC for these expanded indications.