Evidence map›Paper›PMID 30371316›Full record

Observational studyJournal of the American Heart Association2018

Limitations of Specific Coagulation Tests for Direct Oral Anticoagulants: A Critical Analysis.

Matthias Ebner, Ingvild Birschmann, Andreas Peter, Florian Härtig, Charlotte Spencer, Joachim Kuhn, André Rupp, Gunnar Blumenstock, Christine S Zuern, Ulf Ziemann and 1 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
5.3field-weighted citation impact, top 3% 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.

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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Inhibition of thrombin generation 12 hours after intake of direct oral anticoagulants.Research and practice in thrombosis and haemostasis · 2020
    Article
  15. Article
  16. Patients on NOACs in the Emergency Room.Current neurology and neuroscience reports · 2019
    Review
  17. Article
  18. Observational
  19. Performance Characteristics of DOAC Dipstick in Determining Direct Oral Anticoagulants in Urine.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
  20. Patients' Plasma Activity of Heparin, low-Molecular-Weight Heparin or no Anticoagulants on Urine Based DOAC Test Strips.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
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

11 authors at 6 institutions in 2 countries.

Matthias Ebner1 Department of Internal Medicine and Cardiology Charité University Medicine Berlin Campus Virchow Klinikum Berlin Germany.
Ingvild Birschmann3 Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center Ruhr University Bad Oeynhausen Germany.
Andreas Peter4 Division of Endocrinology, Diabetology, Angiology, Nephrology and Clinical Chemistry Department of Internal Medicine University Hospital Tübingen Germany.
Florian Härtig2 Department of Neurology with Focus on Neurovascular Diseases and Neurooncology and Hertie Institute for Clinical Brain Research University Hospital Tübingen Germany.
Charlotte Spencer2 Department of Neurology with Focus on Neurovascular Diseases and Neurooncology and Hertie Institute for Clinical Brain Research University Hospital Tübingen Germany.
Joachim Kuhn3 Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center Ruhr University Bad Oeynhausen Germany.
André Rupp7 Department of Neurology University Hospital Heidelberg Heidelberg Germany.
Gunnar Blumenstock8 Department of Clinical Epidemiology and Applied Biometry University of Tübingen Germany.
Christine S Zuern9 Department of Cardiology and Cardiovascular Medicine University Hospital Tübingen Germany.
Ulf Ziemann2 Department of Neurology with Focus on Neurovascular Diseases and Neurooncology and Hertie Institute for Clinical Brain Research University Hospital Tübingen Germany.
Sven Poli2 Department of Neurology with Focus on Neurovascular Diseases and Neurooncology and Hertie Institute for Clinical Brain Research University Hospital Tübingen Germany.
Hertie Institute for Clinical Brain Research · DEHeart and Diabetes Center North Rhine-Westphalia · DEHeidelberg University · DEUniversity Hospital of Basel · CHUniversity of Tübingen · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background During treatment with direct oral anticoagulants ( DOAC ), coagulation assessment is required before thrombolysis, surgery, and if anticoagulation reversal is evaluated. Limited data support the accuracy of DOAC -specific coagulation assays around the current safe-for-treatment threshold of 30 ng/ mL . Methods and Results In 481 samples obtained from 96 patients enrolled at a single center, DOAC concentrations were measured using Hemoclot direct thrombin inhibitor assay, Biophen direct thrombin inhibitor assay or ecarin clotting time for dabigatran, chromogenic anti-Xa assay ( AXA ) for factor Xa inhibitors (rivaroxaban, apixaban) and ultraperformance liquid chromatography-tandem mass spectrometry as reference. All dabigatran-specific assays had high sensitivity to concentrations >30 ng/ mL , but specificity was lower for Hemoclot direct thrombin inhibitor assay (78.2%) than for Biophen direct thrombin inhibitor assay (98.9%) and ecarin clotting time (94.6%). AXA provided high sensitivity and specificity for rivaroxaban, but low sensitivity for apixaban (73.8%; concentrations up to 82 ng/ mL were misclassified as <30 ng/ mL ). If no DOAC -specific calibration for AXA is available, results 2-fold above the upper limit of normal indicate relevant rivaroxaban concentrations. For apixaban, all elevated results should raise suspicion of relevant anticoagulation. Conclusions DOAC -specific tests differ considerably in diagnostic performance for concentrations close to the currently accepted safe-for-treatment threshold. Compared with Biophen direct thrombin inhibitor assay and ecarin clotting time, limited specificity of Hemoclot direct thrombin inhibitor assay poses a high risk of unnecessary anticoagulation reversal or treatment delays in patients on dabigatran. While AXA accurately detected rivaroxaban, the impact of low apixaban levels on the assay was weak. Hence, AXA results need to be interpreted with extreme caution when used to assess hemostatic function in patients on apixaban. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifiers: NCT 02371044, NCT 02371070.

Indexed as

Administration, OralAgedAntithrombinsBlood CoagulationBlood Coagulation TestsDabigatranDose-Response Relationship, DrugFactor Xa InhibitorsFemaleFollow-Up StudiesHumansMalePyrazolesPyridonesRetrospective StudiesRivaroxabanAntithrombinsapixabanDabigatranFactor Xa InhibitorsPyrazolesPyridonesRivaroxabananticoagulation reversalcoagulation testingdirect oral anticoagulantsemergency surgerythrombolysis

Identifiers

PMID30371316
PMCPMC6404908
OpenAlexW2891946521

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.