Dataset Information

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.

SUBMITTER: Solomon C

PROVIDER: S-EPMC5152534 | biostudies-other | 2016 Oct

REPOSITORIES: biostudies-other

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Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

Solomon Cristina C Asmis Lars M LM Spahn Donat R DR

Scandinavian journal of clinical and laboratory investigation 20160629 6

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 h ...[more]

PMID: 27354213

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Project description:BackgroundViscoelastic tests enable a time-efficient analysis of coagulation properties. An important limitation of viscoelastic tests is the complicated presentation of their results in the form of abstract graphs with a multitude of numbers. We developed Visual Clot to simplify the interpretation of presented clotting information. This visualization technology applies user-centered design principles to create an animated model of a blood clot during the hemostatic cascade. In a previous simulation study, we found Visual Clot to double diagnostic accuracy, reduce time to decision making and perceived workload, and improve care providers' confidence.ObjectiveThis study aimed to investigate the opinions of physicians on Visual Clot technology. It further aimed to assess its strengths, limitations, and clinical applicability as a support tool for coagulation management.MethodsThis was a researcher-initiated, international, double-center, mixed qualitative-quantitative study that included the anesthesiologists and intensive care physicians who participated in the previous Visual Clot study. After the participants solved six coagulation scenarios using Visual Clot, we questioned them about the perceived pros and cons of this new tool. Employing qualitative research methods, we identified recurring answer patterns, and derived major topics and subthemes through inductive coding. Based on them, we defined six statements. The study participants later rated their agreement to these statements on five-point Likert scales in an online survey, which represented the quantitative part of this study.ResultsA total of 60 physicians participated in the primary Visual Clot study. Among these, 36 gave an interview and 42 completed the online survey. In total, eight different major topics were derived from the interview field note responses. The three most common topics were "positive design features" (29/36, 81%), "facilitates decision making" (17/36, 47%), and "quantification not made" (17/36, 47%). In the online survey, 93% (39/42) agreed to the statement that Visual Clot is intuitive and easy to learn. Moreover, 90% (38/42) of the participants agreed that they would like the standard result and Visual Clot displayed on the screen side by side. Furthermore, 86% (36/42) indicated that Visual Clot allows them to deal with complex coagulation situations more quickly.ConclusionsA group of anesthesia and intensive care physicians from two university hospitals in central Europe considered Visual Clot technology to be intuitive, easy to learn, and useful for decision making in situations of active bleeding. From the responses of these possible future users, Visual Clot appears to constitute an efficient and well-accepted way to streamline the decision-making process in viscoelastic test-based coagulation management.

Dataset Information

Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

Publications

Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

Similar Datasets

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