1. Evaluation of Four Factor Prothrombin Complex Concentrate
Utilization at a 591 – Bed Teaching Hospital
Brian Auditore, PharmD Candidate1, Shan Wang, PharmD., BCCCP.2, Laura Gianni, PharmD.1, Adel Hanna, MD.2, and Alexander Axelrad, MD2.
1. St. John’s University College of Pharmacy, Jamaica, NY Winthrop-University Hospital, 259 First Street, Mineola NY
Results
Results
Background
Four Factor Prothrombin Complex Concentrate (4F-PCC) is indicated for the urgent reversal of acquired coagulation factor deficiency, induced by Vitamin K antagonist therapy, in patients with acute major bleeding or need for an urgent surgery/invasive procedure.
Possible advantages of 4F-PCC over Fresh Frozen Plasma include: smaller volume to be administered; less risk of infection; is administered more quickly; and has a quicker onset of action. However, 4F-PCC carries a greater risk of thrombosis and is more expensive.
Patients with a history of thrombotic events within 3 months of receiving 4F-PCC were excluded from randomized control trials, therefore it is unknown if 4F-PCC is safe in these patients.
A total of 46 patient medical records were included in this review of which twenty two (48%) were female.
The mean age was 75 years old ( age range = 37-98). Thirty eight (83%) were 65 years or older.
No patient had any contraindication to 4F-PCC. No patient received more than the maximum total dose of 5000 units.
One patient received two doses of 4F-PCC.
Of the 46 patients, 5 (11%) patients received 4F-PCC for an inappropriate indication: 4 patients having an elevated INR less than 7.5 with no active bleeding and 1 patient not having a surgery scheduled.
Seven (15%) patients did not receive the correct dose of 4F-PCC based on their INR levels.
Five (14%) of the 36 patients who received 4F-PCC for warfarin reversal did not receive Vit K concurrently.
Of the 46 patients, 4 had a thrombotic event within 3 months prior to receiving 4F-PCC. Of these 4 patients, 2 (50%) developed DVT following 4F-PCC treatment.
Of the 46 patients, 42 did not have a thrombotic event within 3 months prior to receiving 4F-PCC. Of these 42 patients, 2 (5%) developed DVT following 4F-PCC treatment.
Prescribing Service N = 46
Location of Bleed N = 31 4% 3% 3%
Conclusion
Anticoagulant Needing Reversal N = 46
Concurrent Antiplatelet Agent N = 46 2%
Using 4F-PCC in patients who were not taking an anticoagulant in the absence of a liver coagulopathy may not be beneficial and may increase the risk of thrombotic events (3 out of 4 such patients died and the remaining one developed a deep vein thrombosis).
Patients with a previous recent thrombotic event seem more likely to experience a thrombotic event after receiving 4F-PCC.
The utilization of 4F-PCC appears to be safe and effective when given to patients who are on anticoagulants and who are either actively bleeding or requires emergent surgery/intervention
Objectives
Assess the appropriate use of 4F-PCC in adult patients.
Evaluate the indications, adverse events, and patient outcomes of 4F-PCC treatment.
Methodology
Patients with Thrombotic Event w/in past 3 months N = 46
Reason for Prescribing 4F-PCC N = 46
References 2% 2% 2%
Retrospective chart review of patients who were admitted into Winthrop University Hospital and received 4F-PCC from January 1, 2016 to June 30, 2016.
A data collection form was created and used to collect pertinent information on the use of 4F-PCC in these patients.
Data was subsequently entered into a spreadsheet and analyzed.
Pabinger I, Brenner B, Kalina U, et al. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. Journal of Thrombosis and Haemostasis 2008; 6:
Kcentra [package insert]. CSL Behring, King of Prussia, PA; September Accessed Jan 3, 2017.
Goldstein JN, Refaai MA, Milling TJ, Jr, et al. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet 2015;385:
Additional References available upon request.