Evidence map›Paper›PMID 30443817›Full record

Observational studyJournal of thrombosis and thrombolysis2019

Low-dose compared to manufacturer-recommended dose four-factor prothrombin complex concentrate for acute warfarin reversal.

Wesley Zemrak, Francis Manuel, Kathryn E Smith, Stephen Rolfe, Timothy Hayes, Robert L Trowbridge, Brian Carlone, David Seder

Abstract readComparative StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of thrombosis and thrombolysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Wesley ZemrakDepartment of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA. zemraw@mmc.org.ORCID http://orcid.org/0000-0002-5046-7966
Francis ManuelDepartment of Pharmacy, Mayo Clinic, Rochester, MN, USA.
Kathryn E SmithDepartment of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA.
Stephen RolfeDepartment of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA.
Timothy HayesDepartment of Pathology, Maine Medical Center, Portland, ME, USA.
Robert L TrowbridgeDepartment of Medicine, Maine Medical Center, Portland, ME, USA.
Brian CarloneDepartment of Pharmacy, Maine Medical Center, Portland, ME, 04105, USA.
David SederDepartment of Critical Care Services, Maine Medical Center, Portland, ME, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFour-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.

methodsA 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.

resultsDemographics, 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%).

conclusionUtilization 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.

Indexed as

AnticoagulantsAgedAged, 80 and overBlood Coagulation FactorsBody WeightDrug Dosage CalculationsDrug MonitoringFemaleHemorrhageHemostasisHeparin AntagonistsHumansInternational Normalized RatioMaleModels, BiologicalRetrospective StudiesAnticoagulantsBlood Coagulation FactorsHeparin Antagonistsprothrombin complex concentratesWarfarinHemorrhagePCCProthrombin complex concentrateReversalWarfarin

Identifiers

PMID30443817

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.