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Tytuł:
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Low-dose compared to manufacturer-recommended dose four-factor prothrombin complex concentrate for acute warfarin reversal.
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Autorzy:
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Zemrak W; Department of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA. .
Manuel F; Department of Pharmacy, Mayo Clinic, Rochester, MN, USA.
Smith KE; Department of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA.
Rolfe S; Department of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA.
Hayes T; Department of Pathology, Maine Medical Center, Portland, ME, USA.
Trowbridge RL; Department of Medicine, Maine Medical Center, Portland, ME, USA.
Carlone B; Department of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA.
Seder D; Department of Critical Care Services, Maine Medical Center, Portland, ME, USA.
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Źródło:
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Journal of thrombosis and thrombolysis [J Thromb Thrombolysis] 2019 Feb; Vol. 47 (2), pp. 263-271.
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Typ publikacji:
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Comparative Study; Journal Article; Observational Study
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Język:
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English
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Imprint Name(s):
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Original Publication: [Dordrecht ; Norwell, MA] : Kluwer Academic Publishers, c1994-
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MeSH Terms:
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Anticoagulants*/administration & dosage
Anticoagulants*/adverse effects
Blood Coagulation Factors/*administration & dosage
Hemorrhage/*drug therapy
Hemostasis/*drug effects
Heparin Antagonists/*administration & dosage
Warfarin/*antagonists & inhibitors
Aged ; Aged, 80 and over ; Blood Coagulation Factors/adverse effects ; Body Weight ; Drug Dosage Calculations ; Drug Monitoring/methods ; Female ; Hemorrhage/chemically induced ; Hemorrhage/diagnosis ; Heparin Antagonists/adverse effects ; Humans ; International Normalized Ratio ; Male ; Models, Biological ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Treatment Outcome ; Warfarin/administration & dosage ; Warfarin/adverse effects
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References:
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Contributed Indexing:
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Keywords: Hemorrhage; PCC; Prothrombin complex concentrate; Reversal; Warfarin
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Substance Nomenclature:
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0 (Anticoagulants)
0 (Blood Coagulation Factors)
0 (Heparin Antagonists)
37224-63-8 (prothrombin complex concentrates)
5Q7ZVV76EI (Warfarin)
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Entry Date(s):
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Date Created: 20181117 Date Completed: 20190617 Latest Revision: 20200225
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Update Code:
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20240105
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DOI:
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10.1007/s11239-018-1768-1
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PMID:
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30443817
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Background: Four-factor PCC is the recommended standard of care for acute warfarin reversal but optimal dosing is unknown. We aim to show that a low-dose strategy is often adequate and may reduce the risk of thromboembolic events when compared to manufacturer-recommended dosing.
Methods: A weight-based dosing strategy of 15-25 units/kg was established as the institutional standard of care in May 2015. This retrospective, before-and-after cohort analysis included patients receiving 4F-PCC according to a manufacturer-recommended (n = 122) or a low-dose (n = 83) strategy. The primary efficacy outcome was a combination of INR reversal on first check and hemostatic efficacy at 24 h.
Results: Demographics, indications for warfarin, and presenting INR values were similar between the two groups. Patients in the manufacturer-recommended dose group received significantly more 4F-PCC than the low dose group (2110 units vs. 1530 units). More patients in the manufacturer-recommended dose group achieved the primary endpoint (75.4% vs. 61.4%), with more patients achieving the target INR on recheck in the manufacturer-recommended dose group (95.9% vs. 84.3%) and no difference in hemostatic efficacy between groups (79.5% vs. 74.7%). There was no difference in thromboembolic events at 72 h (4.1% vs. 1.2%) or at 30 days (8.2% vs. 4.8%). Significantly more patients in the manufacturer-recommended dose group died or were transferred to hospice care during hospitalization (21.3% vs. 9.6%).
Conclusion: Utilization of a low-dose 4F-PCC strategy resulted in fewer patients achieving target INR reversal, but no difference in hemostatic efficacy, thromboembolic events, or survival.