Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates

Area of Science:

• Hematology
• Pharmacology
• Clinical Medicine

Background:

• Prothrombin complex concentrates (PCCs) are crucial for urgent warfarin reversal and managing bleeding associated with novel oral anticoagulants.
• PCCs are indicated in patients experiencing acute major bleeding or requiring urgent procedures.
• Evaluating the real-world effectiveness and safety of PCC usage is essential for clinical practice.

Purpose of the Study:

• To assess the effectiveness and safety of prothrombin complex concentrate (PCC) administration.
• To determine the time to achieve a target INR of ≤1.3 post-PCC.
• To evaluate the incidence of thromboembolic events following PCC use.

Main Methods:

• Retrospective review of electronic medical records from July 2013 to April 2014 across twelve tertiary care hospitals.
• Inclusion criteria: patients receiving commercially available PCCs (KCentra® or Profilnine®).
• Data analysis focused on INR reversal, hemoglobin levels, and thromboembolic complications.

Main Results:

• A total of 193 patients received PCC; 184 received four-factor PCC.
• Target INR ≤1.3 was achieved in 65.8% of patients within a median of 8.03 hours.
• An acute venous thromboembolism occurred in 4.1% of patients.

Conclusions:

• Four-factor PCC demonstrates effectiveness in achieving INR reversal in patients requiring urgent anticoagulation management.
• PCC usage is associated with a low incidence of venous thromboembolism, suggesting a favorable safety profile.
• Four-factor PCC represents a viable and effective alternative to fresh frozen plasma for anticoagulation reversal.