2021
DOI: 10.1177/1060028021992142
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Evaluation of a Fixed-Dose Regimen of 4-Factor Prothrombin Complex Concentrate for Warfarin Reversal

Abstract: Background: Fixed-dose (FD) regimens of 4-factor prothrombin complex concentrate (4F-PCC) may be effective for the emergent reversal of warfarin; however, the optimal dosing is unknown. Our institution transitioned to a FD regimen of 1000 or 2000 units of 4F-PCC based on indication. Objective: The purpose of this study is to report our experience with FD 4F-PCC compared with a historical weight-based dosing cohort for warfarin reversal. Methods: A retrospective analysis was conducted for 3 groups: central nerv… Show more

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Cited by 5 publications
(6 citation statements)
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References 11 publications
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“…1 ; and Supplementary Table 2 , http://links.lww.com/CCM/H489 ). Three studies were prospective RCTs ( 8 10 ), one was a prospective cohort of both treatment regimens ( 29 ), two were prospective cohorts treated with a fixed-dose regimen compared with historical data ( 28 , 38 ), and the remainder were retrospective studies ( 13 , 14 , 16 , 17 , 25 27 , 30 , 32 , 34 , 39 41 ). All studies were conducted in the United States or The Netherlands.…”
Section: Resultsmentioning
confidence: 99%
See 2 more Smart Citations
“…1 ; and Supplementary Table 2 , http://links.lww.com/CCM/H489 ). Three studies were prospective RCTs ( 8 10 ), one was a prospective cohort of both treatment regimens ( 29 ), two were prospective cohorts treated with a fixed-dose regimen compared with historical data ( 28 , 38 ), and the remainder were retrospective studies ( 13 , 14 , 16 , 17 , 25 27 , 30 , 32 , 34 , 39 41 ). All studies were conducted in the United States or The Netherlands.…”
Section: Resultsmentioning
confidence: 99%
“…Variable-dose regimens all followed the respective manufacturers’ recommendations. Four studies included only patients with ICH ( 27 , 30 , 32 , 39 ), whereas another three studies included subgroup analysis for ICH patients ( 17 , 25 , 34 ). ICH patients were specifically excluded from four studies ( 10 , 14 , 28 , 29 ).…”
Section: Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…Kcentra is the only FDA-approved four factor PCC for managing warfarin-associated coagulopathies and is recommended by several national societies [ 3 , 4 , 5 , 6 ]. Traditionally, Kcentra is dosed based on the patient’s weight and INR but is also given as a low fixed-dose [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. A low fixed-dose approach offers several advantages over traditional dosing, including decreased time to administration and costs.…”
Section: Introductionmentioning
confidence: 99%
“…Despite the positive results of several studies, FEIBA is not formally recognized by national societies as a therapeutic option for managing warfarin-associated coagulopathies [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ]. This finding may be driven by FEIBA lacking an FDA approval for this indication, the relatively small number of studies evaluating the use of FEIBA in the management of warfarin-associated coagulopathies compared to PCC, and the preconceived notion that FEIBA is more prothrombotic than PCC due to it containing activated factor VII.…”
Section: Introductionmentioning
confidence: 99%