ArticleJournal of thrombosis and thrombolysis2018
Fixed dose 4-factor prothrombin complex concentrate for the emergent reversal of warfarin: a retrospective analysis.
Article in Journal of thrombosis and thrombolysis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparison of 4-factor fixed-dose versus 4-factor weight-based-dose prothrombin complex concentrate for emergent warfarin reversal: a systematic review and meta-analysis.Clinical and experimental emergency medicine · 2025Pooled it
- Safety and efficacy of fixed versus variable-dose prothrombin complex concentrate for emergent reversal of vitamin K antagonists: A systematic review and meta-analysis.The American journal of emergency medicine · 2024Pooled it
- A Novel Fixed-Dose Activated Prothrombin Complex Concentrate Regimen for Warfarin-Associated Hemorrhages: A Retrospective Cohort Comparison of Two Regimens.Pharmacy (Basel, Switzerland) · 2026Article
- Fixed-Dose Four-Factor Prothrombin Complex Concentrate for Reversal of Anticoagulation: Evaluation of Efficacy, Safety, and Cost Savings.Journal of hematology · 2025Article
- Evaluation of modified fixed dose four-factor prothrombin complex concentrate for warfarin reversal.Journal of thrombosis and thrombolysis · 2024Article
- A retrospective comparison of the emergent use of fixed-dose four-factor prothrombin complex versus weight-based dosing for intracranial hemorrhage assessing medication delivery time and cost.International journal of physiology, pathophysiology and pharmacology · 2023Article
- Fixed-Dose Factor Eight Inhibitor Bypassing Activity (FEIBA) in the Management of Warfarin-Associated Coagulopathies.Pharmacy (Basel, Switzerland) · 2022Article
- Comparison of 4F-PCC in obese and nonobese patients with life-threatening bleeding or requiring emergent surgery.Research and practice in thrombosis and haemostasis · 2021Article
- Safety and effectiveness of a four-factor prothrombin complex concentrate for vitamin K antagonist reversal following a fixed-dose strategy.European journal of hospital pharmacy : science and practice · 2021Article
- Fixed- versus variable-dose prothrombin complex concentrate protocol for vitamin K antagonist reversal.International journal of hematology · 2021Article
- Clinical utilization of four-factor prothrombin complex concentrate: a retrospective single center study.Clinical and experimental emergency medicine · 2021Article
- Initiation of a fixed-dose four-factor prothrombin complex concentrate protocol.Journal of thrombosis and thrombolysis · 2020Article
- Collaborative Management Strategies for Drug Shortages in Neurocritical Care.Neurocritical care · 2020Review
- High-Dose 4-Factor Prothrombin Complex Concentrate for Warfarin-Induced Intracranial Hemorrhage.The Neurohospitalist · 2020Article
- Low-dose compared to manufacturer-recommended dose four-factor prothrombin complex concentrate for acute warfarin reversal.Journal of thrombosis and thrombolysis · 2019Observational
- Fixed-dose 4-factor prothrombin complex concentrate: we don't know where we're going if we don't know how to get there.Journal of thrombosis and thrombolysis · 2018Review
- Clinical protocols for oral anticoagulant reversal during high risk of bleeding for emergency surgical and nonsurgical settings: a narrative review.Brazilian journal of anesthesiology (Elsevier)Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Published literature suggests that a fixed-dose 4-factor prothrombin complex concentrate (4FPCC) may be efficacious in managing warfarin-associated hemorrhage, however the ideal dose is still unclear. The purpose of this evaluation was to determine the efficacy of fixed-dose 4FPCC in reducing the International Normalized Ratio (INR) to ≤ 1.5 among warfarin patients with need for urgent or emergent anticoagulation reversal. Starting October 2016, our institution changed from standard 4FPCC FDA-labeled dosing based on the patient's presenting INR and weight, to a fixed-dose of 1500 units for all patients requiring urgent or emergent warfarin reversal. We conducted a retrospective evaluation, after implementation, with the primary outcome being the proportion of patients who achieved an INR ≤ 1.5 with a single fixed-dose of 1500 units of 4FPCC. Secondary outcomes assessed included: medication turnaround times, attainment of target INR ≤ 2 or clinical hemostasis (as judged by the prescribing provider), use of rescue doses, thrombotic events, and cost savings. A total of 37 patients were included in the analysis. Almost 75% of patients achieved an INR ≤ 1.5 after a single fixed dose of 1500 units, and 100% of patients achieved an INR ≤ 2. The median pre- and post-dose INRs were 3.06 and 1.32 respectively. Based on this evaluation, the administration of a fixed dose of 1500 units 4FPCC, was shown to be effective in adequately reversing the INR in the majority of patients with minimal thrombotic risks.
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Registered trials
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