Savannah Jones
University of North Carolina Hospitals
Chapel Hill, North Carolina
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Title: Evaluation of 4-factor PCC for hemostasis and coagulopathy reversal in non-anticoagulated patients
Introduction: Four-factor prothrombin complex concentrate (4F-PCC) is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist therapy. Off-label use has been described in patients with other causes of coagulopathy; however, the clinical benefit in these populations remains uncertain. The aim of this retrospective analysis was to characterize the use of 4F-PCC in patients with coagulopathies not induced by pharmacological anticoagulation.
Methods: A retrospective chart review of patients who received 4F-PCC between May 1, 2020 and May 30, 2021 was conducted. Patients < 18 years of age and patients on therapeutic anticoagulation at time of administration were excluded. The following data were collected: cause of coagulopathy, dose of 4F-PCC, coagulation labs, and blood products administered. The primary outcome was INR reduction in perioperative bleeding versus other indications. Secondary outcomes included post 4F-PCC INR < 1.5 and number of blood products (pRBCs, cryo, FFP) received. Safety outcomes included new thrombosis after administration of 4F-PCC.
Results: A total of 42 non-anticoagulated patients received 56 doses of 4F-PCC within the study period. The most common indication was perioperative bleeding (n = 24; 52%) followed by emergent surgery (n = 8; 14.3%) and liver disease (n = 8; 14.3%). The average INR was 2.09 in the perioperative group and 2.55 in the combined, other coagulopathy group. Following administration, the average INR reduction was 1.02 and 1.25 (p = 0.38), respectively. In the patients with perioperative bleeding, 55% of doses were administered with INRs < 1.5. Patients who received 4F-PCC for perioperative bleeding were more likely to receive other blood product. There were no thrombotic events following KCentra administration within the study population.
Conclusions: Our findings suggests that 4F-PCC may benefit patients with coagulopathies unrelated to anticoagulant factor deficiency. There was a trend of a greater INR decrease in those who received 4F-PCC for indications outside of perioperative bleeding. While there were no thrombotic events in this cohort, given the high cost and unclear benefit of 4F-PCC in perioperative bleeding, further investigation in this patient population is warranted to guide use.