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A Retrospective Comparison of 3-Factor Prothrombin Complex Concentrate Products for Warfarin Reversal.
Neurohospitalist. 2020 Jul; 10(3):201-207.N

Abstract

Background and Purpose

Current guidelines suggest that 3-factor prothrombin complex concentrate is a possible alternative to 4-factor products for the emergent reversal of bleeding secondary to warfarin. While multiple observational studies have evaluated various forms of 3-factor prothrombin complex concentrate individually, no study has compared the efficacy of the 2 products. The purpose of this study is to compare the efficacy and safety of Bebulin™ and Profilnine™ for the emergent reversal of warfarin-associated major bleeding.

Methods

We conducted a retrospective cohort study of patients receiving both Bebulin™ and Profilnine™ at an urban, academic medical center with comprehensive stroke center designation and a neurosurgical center of excellence. All patients were treated at a single center that utilized a fixed, weight-based dosing protocol. The primary outcome was the percentage of patients in each group achieving a goal international normalization ratio of 1.4 or less.

Results

There was a significant difference in goal international normalization ratio achieved favoring Bebulin™ (85.5% vs 27.3%; P < .001) over Profilnine™. Median dose per kilogram of actual body weight was the same between the groups. When we assessed results by baseline™ international normalization ratio subgroup, more patients in the Bebulin™ group achieved goal when baseline values were 6 or less. No thrombotic events were documented in either group.

Conclusions

We found that patients treated with Bebulin™ experienced significantly higher rates of successful international normalization ratio reversal when compared to those who received Profilnine™. Further research is needed to determine the comparative efficacy between the 2 agents.

Authors+Show Affiliations

Department of Pharmacy, Methodist University Hospital, Memphis, TN, USA. Department of Clinical Pharmacy, University of Tennessee Health Sciences Center (UTHSC), Memphis, TN, USA. Departments of Neurology and Neurosurgery, UTHSC, Memphis, TN, USA.Department of Pharmacy, Methodist University Hospital, Memphis, TN, USA. Department of Clinical Pharmacy, University of Tennessee Health Sciences Center (UTHSC), Memphis, TN, USA.Department of Pharmacy, Baptist Medical Center, Jacksonville, FL, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32549944

Citation

Jones, G Morgan, et al. "A Retrospective Comparison of 3-Factor Prothrombin Complex Concentrate Products for Warfarin Reversal." The Neurohospitalist, vol. 10, no. 3, 2020, pp. 201-207.
Jones GM, Cave B, Cook R. A Retrospective Comparison of 3-Factor Prothrombin Complex Concentrate Products for Warfarin Reversal. Neurohospitalist. 2020;10(3):201-207.
Jones, G. M., Cave, B., & Cook, R. (2020). A Retrospective Comparison of 3-Factor Prothrombin Complex Concentrate Products for Warfarin Reversal. The Neurohospitalist, 10(3), 201-207. https://doi.org/10.1177/1941874420905755
Jones GM, Cave B, Cook R. A Retrospective Comparison of 3-Factor Prothrombin Complex Concentrate Products for Warfarin Reversal. Neurohospitalist. 2020;10(3):201-207. PubMed PMID: 32549944.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Retrospective Comparison of 3-Factor Prothrombin Complex Concentrate Products for Warfarin Reversal. AU - Jones,G Morgan, AU - Cave,Brandon, AU - Cook,Ryan, Y1 - 2020/03/04/ PY - 2021/07/01/pmc-release PY - 2020/6/19/entrez PY - 2020/6/19/pubmed PY - 2020/6/19/medline KW - anticoagulation therapy KW - hematology KW - hemorrhagic disorders KW - prothrombin SP - 201 EP - 207 JF - The Neurohospitalist JO - Neurohospitalist VL - 10 IS - 3 N2 - Background and Purpose: Current guidelines suggest that 3-factor prothrombin complex concentrate is a possible alternative to 4-factor products for the emergent reversal of bleeding secondary to warfarin. While multiple observational studies have evaluated various forms of 3-factor prothrombin complex concentrate individually, no study has compared the efficacy of the 2 products. The purpose of this study is to compare the efficacy and safety of Bebulin™ and Profilnine™ for the emergent reversal of warfarin-associated major bleeding. Methods: We conducted a retrospective cohort study of patients receiving both Bebulin™ and Profilnine™ at an urban, academic medical center with comprehensive stroke center designation and a neurosurgical center of excellence. All patients were treated at a single center that utilized a fixed, weight-based dosing protocol. The primary outcome was the percentage of patients in each group achieving a goal international normalization ratio of 1.4 or less. Results: There was a significant difference in goal international normalization ratio achieved favoring Bebulin™ (85.5% vs 27.3%; P < .001) over Profilnine™. Median dose per kilogram of actual body weight was the same between the groups. When we assessed results by baseline™ international normalization ratio subgroup, more patients in the Bebulin™ group achieved goal when baseline values were 6 or less. No thrombotic events were documented in either group. Conclusions: We found that patients treated with Bebulin™ experienced significantly higher rates of successful international normalization ratio reversal when compared to those who received Profilnine™. Further research is needed to determine the comparative efficacy between the 2 agents. SN - 1941-8744 UR - https://www.unboundmedicine.com/medline/citation/32549944/A_Retrospective_Comparison_of_3-Factor_Prothrombin_Complex_Concentrate_Products_for_Warfarin_Reversal L2 - http://journals.sagepub.com/doi/full/10.1177/1941874420905755?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
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