Impact of rivaroxaban on point-of-care assays

Fontana, Pierre; Alberio, Lorenzo; Angelillo‐Scherrer, Anne; Asmis, Lars M.; Korte, Wolfgang; Méndez, Adriana; Schmid, Pirmin; Stricker, Hans; Studt, Jan‐Dirk; Tsakiris, Dimitrios Α.; Wuillemin, Walter A.; Nagler, Michael

doi:10.1016/j.thromres.2017.03.019

Cited by 29 publications

(30 citation statements)

References 38 publications

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“…Casutt et al previously reported no impact on MCF (EXTEM and INTEM) after intake of 10 mg rivaroxaban. Contrariwise, Fontana et al observed a small (+2 mm) but statistically significant increase in EXTEM MCF 3 hours after administration of 20 mg rivaroxaban in healthy volunteers, but they did not observe a significant impact on INTEM MCF and FIBTEM MCF. Martin et al observed no influence on EXTEM MCF in blood spiked with apixaban …”

Section: Discussionmentioning

confidence: 90%

Impact of four direct oral anticoagulants on rotational thromboelastometry (ROTEM)

Seyve

Richarme

Polack

et al. 2017

Int J Lab Hematology

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Section: Discussionmentioning

confidence: 90%

Impact of four direct oral anticoagulants on rotational thromboelastometry (ROTEM)

Seyve

Richarme

Polack

et al. 2017

Int J Lab Hematology

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“…The DOAC plasma concentration is the most important factor that determines whether an active reversal of medication is necessary. Increasing DOAC plasma levels have been shown to progressively affect laboratory [748] and viscoelastic coagulation tests [257, 749–751] and produce increased bleeding volume in laboratory animals with standardised injuries [752]. Early assessment of both laboratory coagulation tests and direct measurements of DOAC levels, therefore, is crucial in trauma patients receiving or suspected of having received DOAC [753].…”

Section: Resultsmentioning

confidence: 99%

“…Viscoelastic coagulation tests may also be helpful, since DOAC, but not therapeutic levels of VKA, prolong the clotting time (ROTEM®) and reaction (R) time (TEG®) progressively, along with increasing DOAC plasma concentration. However, if the patient has a trauma-induced coagulopathy, it will not be possible to discriminate between the effects of each possible prior treatment [257, 749–751].…”

Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

et al. 2019

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Background: Severe traumatic injury continues to present challenges to healthcare systems around the world, and post-traumatic bleeding remains a leading cause of potentially preventable death among injured patients. Now in its fifth edition, this document aims to provide guidance on the management of major bleeding and coagulopathy following traumatic injury and encourages adaptation of the guiding principles described here to individual institutional circumstances and resources. Methods: The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004, and the current author group included representatives of six relevant European professional societies. The group applied a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reexamined and revised based on scientific evidence that has emerged since the previous edition and observed shifts in clinical practice. New recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. Results: Advances in our understanding of the pathophysiology of post-traumatic coagulopathy have supported improved management strategies, including evidence that early, individualised goal-directed treatment improves the outcome of severely injured patients. The overall organisation of the current guideline has been designed to reflect the clinical decision-making process along the patient pathway in an approximate temporal sequence. Recommendations are grouped behind the rationale for key decision points, which are patient-or problem-oriented rather than related to specific treatment modalities. While these recommendations provide guidance for the diagnosis and treatment of major bleeding and coagulopathy, emerging evidence supports the author group's belief that the greatest outcome improvement can be achieved through education and the establishment of and adherence to local clinical management algorithms. Conclusions: A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. If incorporated into local practice, these clinical practice guidelines have the potential to ensure a uniform standard of care across Europe and beyond and better outcomes for the severely bleeding trauma patient.

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“…Specific tests have emerged as the most suitable solution for the determination of DOAC plasma concentrations and may be used in emergency situations with a turnaround time around 30 min. Studies are ongoing to further reduce this turn around time or to implement point‐of‐care tests . The cost of these specific tests has also been questioned.…”

Section: Discussionmentioning

confidence: 99%

Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians

Douxfils

Ageno

Samama

et al. 2018

Journal of Thrombosis and Haemostasis

291

366

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To cite this article: Douxfils J, Ageno W, Samama C-M, Lessire S, ten Cate H, Verhamme P, Dogn e J-M, Mullier F. Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians. J Thromb Haemost 2018; 16: 209-19. Click to hear Dr Baglin's perspective on the role of the laboratory in treatment with new oral anticoagulants Summary. One of the key benefits of the direct oral anticoagulants (DOACs) is that they do not require routine laboratory monitoring. Nevertheless, assessment of DOAC exposure and anticoagulant effects may become useful in various clinical scenarios. The five approved DOACs (apixaban, betrixaban, dabigatran etexilate, edoxaban and rivaroxaban) have different characteristics impacting assay selection and the interpretation of results. This article provides an updated overview on (i) which test to use (and their advantages and limitations), (ii) when to assay DOAC levels, (iii) how to interpret the results relating to bleeding risk, emergency situations and perioperative management, and (iv) what is the impact of DOACs on routine and specialized coagulation assays. Assays for anti-Xa or anti-IIa activity are the preferred methods when quantitative information is useful, although the situations in which to test for DOAC levels are still debated. Different reagent sensitivities and variabilities in laboratory calibrations impact assay results. International calibration standards for all specific tests for each DOAC are needed to reduce the inter-laboratory variability and allow inter-study comparisons. The impact of the DOACs on hemostasis testing may cause falsepositive or false-negative results; however, these can be minimized by using specific assays and collecting blood samples at trough concentrations. Finally, prospective clinical trials are needed to validate the safety and efficacy of proposed laboratory thresholds in relation to clinical decisions. We offer recommendations on the tests to use for measuring DOACs and practical guidance on laboratory testing to help patient management and avoid diagnostic errors.

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Impact of rivaroxaban on point-of-care assays

Cited by 29 publications

References 38 publications

Impact of four direct oral anticoagulants on rotational thromboelastometry (ROTEM)

Impact of four direct oral anticoagulants on rotational thromboelastometry (ROTEM)

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians

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