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On‐label compared to off‐label four‐factor prothrombin complex concentrate use: a retrospective, observational study
Author(s) -
Cho Brian C.,
Jung YounHoa,
DeMario Vincent M.,
Lau Edward,
Podlasek Stanley J.,
Grant Michael C.,
Gehrie Eric A.,
Frank Steven M.
Publication year - 2019
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.15355
Subject(s) - prothrombin complex concentrate , medicine , off label use , coagulopathy , retrospective cohort study , vitamin k , vitamin k antagonist , prothrombin complex , observational study , cohort , food and drug administration , coagulation , pediatrics , surgery , warfarin , pharmacology , atrial fibrillation
BACKGROUND Four‐factor prothrombin complex concentrate (4F‐PCC) is US Food and Drug Administration approved for the urgent reversal of coagulation factor deficiency induced by a vitamin K antagonist complicated by acute major bleeding or in situations in which invasive procedures are urgently needed. Although recent evidence suggests the superiority of 4F‐PCC over plasma for on‐label indications, the off‐label use of 4F‐PCC has not been rigorously studied. STUDY DESIGN AND METHODS Eighty‐nine patients receiving 4F‐PCC at a single institution from July 2016 to December 2017 were retrospectively analyzed. Two cohorts, “On‐Label” and “Off‐Label” uses of 4F‐PCC, were evaluated, comparing patient characteristics, blood utilization, and clinical outcomes including in‐hospital mortality. RESULTS Patients receiving 4F‐PCC for off‐label reasons (n = 46) were younger and sicker compared to those receiving 4F‐PCC for on‐label reasons (n = 43). Notably, the mortality rate for off‐label use was approximately twofold greater than the mortality rate for on‐label use (26 of 46 [56.5%] vs. 12 of 43 [27.9%]; p = 0.006). Patients receiving 4F‐PCC for off‐label reasons received more units per patient of each blood component than their on‐label counterparts. The average cost estimate per patient for 4F‐PCC was similar (approx. $4300) in each cohort. CONCLUSION 4F‐PCC is an effective but expensive treatment option for those requiring urgent reversal of vitamin K antagonist–induced coagulopathy. However, providers should be conscious of the high costs and questionable efficacy when using 4F‐PCC off‐label.