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The use of 4F‐PCC to correct direct oral anticoagulant‐induced coagulopathy: An observational analysis
Author(s) -
Zheng Yan,
Tormey Christopher A.
Publication year - 2020
Publication title -
transfusion medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.471
H-Index - 59
eISSN - 1365-3148
pISSN - 0958-7578
DOI - 10.1111/tme.12683
Subject(s) - medicine , coagulopathy , observational study , prothrombin complex concentrate , vitamin k antagonist , pulmonary embolism , anesthesia , atrial fibrillation , warfarin
Background With the approval of four‐factor prothrombin complex concentrate (4F‐PCC, Kcentra) for the reversal of vitamin K antagonist‐associated bleeding in the United States, it has become a relatively common practice for 4F‐PCC to be used in an “off‐label” fashion to correct coagulopathy caused by direct oral anticoagulants (DOACs). However, the efficacy and safety of 4F‐PCC have not been well studied in this scenario. Materials and Methods We performed a retrospective observational study on the off‐label use of 4F‐PCC for reversing bleeding associated with DOACs in a level 1 trauma centre between November 2014 and February 2017. International normalised ratio (INR) and Hgb prior to and post 4F‐PCC infusion, clinical outcome and thromboembolic events within 24 hours and 45 days of 4F‐PCC administration were collected. Results We identified 24 patients on DOACs who received 4F‐PCC for severe haemorrhage and emergent surgeries. Most patients showed improved haemorrhage as demonstrated by stabilised intracranial haemorrhage sizes and/or by steady Hgb levels. No thromboembolic event was identified within 24 hours of 4F‐PCC administration. However, 16.7% patients (4/24) experienced thromboembolic events 2 to 45 days after receiving 4F‐PCC. Conclusion Our data showed that 4F‐PCC was relatively efficient in correcting DOAC‐induced coagulopathy. We did notice that 16.7% of patients experienced some form of thromboembolic events in the days‐to‐weeks after 4F‐PCC administration, although the imputability of 4F‐PCC in these processes (vs their underlying disease) is difficult to determine. Additional prospective studies would be warranted to further evaluate the safety of 4F‐PCC for this off‐label indication.