Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

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.

Keywords:

• Blood coagulation tests
• diagnostic techniques and procedures
• thrombelastography
• thromboelastometry

Acknowledgements

Editorial assistance was provided by Meridian HealthComms Ltd, funded by CSL Behring.

Disclosure statement

Cristina Solomon is an employee of CSL Behring and previously received speaker honoraria and research support from Tem International and CSL Behring, and travel support from Haemoscope Ltd (former manufacturer of TEG). Lars Asmis has received speaker honoraria or research support from Axon Lab, Bayer, Boehringer Ingelheim, CSL Behring, GlaxoSmithKline, Pfizer, Sanofi Aventis and Vifor. Donat R. Spahn has received honoraria or travel support for consulting or lecturing from the following companies: Abbott AG, Baar, Switzerland; AMGEN GmbH, Munich, Germany; AstraZeneca AG, Zug, Switzerland; Bayer (Schweiz) AG, Zürich, Switzerland; Baxter AG, Volketswil, Switzerland; Baxter S.p.A., Roma, Italy; B. Braun Melsungen AG, Melsungen, Germany; Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland; Bristol-Myers-Squibb, Rueil-Malmaison Cedex, France, and Baar, Switzerland; CSL Behring GmbH, Hattersheim am Main, Germany, and Berne, Switzerland; Curacyte AG, Munich, Germany; Ethicon Biosurgery, Sommerville, NJ, USA; Fresenius SE, Bad Homburg v.d.H., Germany; Galenica AG, Bern, Switzerland (including Vifor SA, Villars-sur-Glâne, Switzerland); GlaxoSmithKline GmbH & Co. KG, Hamburg, Germany; Janssen-Cilag AG, Baar, Switzerland; Janssen-Cilag EMEA, Beerse, Belgium; Merck Sharp & Dohme AG, Luzern, Switzerland; Novo Nordisk A/S, Bagsvärd, Denmark; Octapharma AG, Lachen, Switzerland; Organon AG, Pfäffikon/SZ, Switzerland; Oxygen Biotherapeutics, Costa Mesa, CA, USA; Photonics Healthcare GmbH, Munich, Germany; ratiopharm Arzneimittel Vertriebs-GmbH, Vienna, Austria; Roche Diagnostics International Ltd, Reinach, Switzerland; Roche Pharma (Schweiz) AG, Reinach, Switzerland; Schering-Plough International, Inc., Kenilworth, NJ, USA; Tem International GmbH, Munich, Germany; Verum Diagnostica GmbH, Munich, Germany; Vifor Pharma Deutschland GmbH, Munich, Germany; Vifor Pharma Österreich GmbH, Vienna, Austria; and Vifor (International) AG, St. Gallen, Switzerland.