Evidence map›Paper›PMID 33641678›Full record

ArticleNeurological research and practice2021

Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban.

Florian Härtig, Ingvild Birschmann, Andreas Peter, Sebastian Hörber, Matthias Ebner, Matthias Sonnleitner, Charlotte Spencer, Paula Bombach, Maria-Ioanna Stefanou, Johannes Tünnerhoff and 4 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Neurological research and practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02825394 (Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 8% of its field
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.

NCT02825394 unknown statusnot on this map

Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1

TypeobservationalSponsorUniversity Hospital TuebingenRan2016 to 2021Enrolled160ConditionsAnticoagulation With NOACArmsanti-Xa activity point-of-care testing (aXa-POCT), ecarin clotting time point-of-care testing (ECT-POCT)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
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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

14 authors at 4 institutions in 1 country.

Florian HärtigDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Ingvild BirschmannInstitute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University, Bad Oeynhausen, Germany.
Andreas PeterDepartment of Diagnostic Laboratory Medicine, Institue for Clinical Chemistry and Pathobiochemistry, Eberhard-Karls University Tübingen, Tübingen, Germany.
Sebastian HörberDepartment of Diagnostic Laboratory Medicine, Institue for Clinical Chemistry and Pathobiochemistry, Eberhard-Karls University Tübingen, Tübingen, Germany.
Matthias EbnerDepartment of Nephrology and Medical Intensive Care, Charité University Medicine, Berlin, Germany.
Matthias SonnleitnerDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Charlotte SpencerDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Paula BombachDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Maria-Ioanna StefanouDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Johannes TünnerhoffDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Annerose MengelDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Joachim KuhnInstitute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University, Bad Oeynhausen, Germany.
Ulf ZiemannDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.
Sven PoliDepartment of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. sven.poli@uni-tuebingen.de.ORCID http://orcid.org/0000-0002-0286-8781
Hertie Institute for Clinical Brain Research · DEHeart and Diabetes Center North Rhine-Westphalia · DEUniversity of Tübingen · DECharité - Universitätsmedizin Berlin · DE

Funding

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6 · The paper itself

Abstract

backgroundDirect oral anticoagulants (DOAC) including edoxaban are increasingly used for stroke prevention in atrial fibrillation. Despite treatment, annual stroke rate in these patients remains 1-2%. Rapid assessment of coagulation would be useful to guide thrombolysis or reversal therapy in this growing population of DOAC/edoxaban-treated stroke patients. Employing the Hemochron™ Signature Elite point-of-care test system (HC-POCT), clinically relevant plasma concentrations of dabigatran and rivaroxaban can be excluded in a blood sample. However, no data exists on the effect of edoxaban on HC-POCT results. We evaluated whether edoxaban plasma concentrations above the current treatment thresholds for thrombolysis or anticoagulation reversal (i.e., 30 and 50 ng/mL) can be ruled out with the HC-POCT.

methodsWe prospectively studied patients receiving a first dose of edoxaban. Six blood samples were collected from each patient: before, 0.5, 1, 2, 8, and 24 h after drug intake. HC-POCT-based INR (HC-INR), activated clotting time (HC-ACT+ and HC-ACT-LR), activated partial thromboplastin time (HC-aPTT), and mass spectrometry for edoxaban plasma concentrations were performed at each time-point. We calculated correlations, receiver operating characteristics (ROC) and test-specific cut-offs for ruling out edoxaban concentrations > 30 and > 50 ng/mL in a blood sample.

resultsOne hundred twenty blood samples from 20 edoxaban-treated patients were analyzed. Edoxaban plasma concentrations ranged from 0 to 512 ng/mL. HC-INR/HC-ACT+/HC-ACT-LR/HC-aPTT ranged from 0.7-8.3/78-310 s/65-215 s/19-93 s, and Pearson's correlation coefficients showed moderate to very strong correlations with edoxaban concentrations (r = 0.95/0.79/0.70/0.60). With areas under the ROC curve of 0.997 (95% confidence interval: 0.991-0.971) and 0.989 (0.975-1.000), HC-INR most reliably ruled out edoxaban concentrations > 30 and > 50 ng/mL, respectively, and HC-INR results ≤1.5 and ≤ 2.1 provided specificity/sensitivity of 98.6% (91.2-99.9)/98.0% (88.0-99.9) and 96.8% (88.0-99.4)/96.5% (86.8-99.4).

conclusionsOur study represents the first systematic evaluation of the HC-POCT in edoxaban-treated patients. Applying sufficiently low assay-specific cut-offs, the HC-POCT may not only be used to reliably rule out dabigatran and rivaroxaban, but also very low edoxaban concentrations in a blood sample. Because the assay-specific cut-offs were retrospectively defined, further investigation is warranted.

trial registrationClinicalTrials.gov, registration number: NCT02825394 , registered on: 07/07/2016, URL.

Indexed as

Anticoagulation reversalDirect oral anticoagulantsDOACNOACNon-vitamin K antagonist oral anticoagulantsPOCTPoint-of-care testingStrokeThrombolysis

Identifiers

PMID33641678
PMCPMC7919064
OpenAlexW3135760900

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.