ArticleScandinavian journal of clinical and laboratory investigation2016
Is viscoelastic coagulation monitoring with ROTEM or TEG validated?
Article in Scandinavian journal of clinical and laboratory investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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
6 citing papers in PubMed.
- Methodological and Pathophysiological Considerations in Obesity-Associated Thrombosis.International journal of molecular sciences · 2026Review
- Pharmacokinetics and pharmacodynamics of low doses of recombinant tissue plasminogen activator to establish a model for biosimilarity comparisons.Research and practice in thrombosis and haemostasis · 2024Article
- Clinical Validation of Global Coagulation Tests to Guide Blood Component Transfusions in Cirrhosis and ACLF.Journal of clinical and translational hepatology · 2021Article
- Next generation viscoelasticity assays in cardiothoracic surgery: Feasibility of the TEG6s system.PloS one · 2018Article
- Quality Assessment of Established and Emerging Blood Components for Transfusion.Journal of blood transfusion · 2016Review
- Clinical application of viscoelastic point-of-care tests of coagulation-shifting paradigms.Annals of cardiac anaesthesiaReview
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent years have seen increasing worldwide interest in the use of viscoelastic coagulation monitoring tests, performed using devices such as ROTEM and TEG. The use of such tests to guide haemostatic therapy may help reduce transfusion of allogeneic blood products in bleeding patients and is supported in European guidelines for managing trauma and severe perioperative bleeding. In addition, viscoelastic tests form the basis of numerous published treatment algorithms. However, some publications have stated that viscoelastic tests are not validated. A specific definition of the term validation is lacking and regulatory requirements of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have been fulfilled by ROTEM and TEG assays. Viscoelastic tests have been used in pivotal clinical trials, and they are approved for use in most of the world's countries. Provided that locally approved indications are adhered to, the regulatory framework for clinicians to use viscoelastic tests in routine clinical practice is in place.
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Registered trials
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