Prospective cohort study on the use of low molecular weight heparin calibrated anti-Xa assay for measurement of direct oral Xa inhibitors in ex vivo patient samples

Lim, Ming Sheng; Hayes, Robert C.; Sharma, Archna; Kitiponchai, Tanun; Mohamed, Muhajir; McRae, Simon

doi:10.1016/j.pathol.2022.01.004

Cited by 5 publications

(6 citation statements)

References 23 publications

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“…Second, although specific quantification of plasma DOAC drug levels determined by specific coagulation assays (dilute thrombin time [TT], ecarin clotting time for dabigatran, and calibrated anti-FXa chromogenic assays) is well validated for precision and monitored by external quality assurance programs [ 32 , 40 , [45] , [46] , [47] , [48] ], the clinical demand and hospital awareness for implementing a rapid DOAC level, such as an INR result in an emergency, are lacking. One recent advance to simplify obtaining an anti-FXa result to make it more feasible in an emergency is the current data supporting using the low-molecular-weight heparin anti-FXa calibration curve to calculate a conversion factor for plasma rivaroxaban, apixaban, and edoxaban levels [ 49 , 50 ].…”

Section: Discussionmentioning

confidence: 99%

Direct oral anticoagulants or vitamin K antagonists in emergencies: comparison of management in an observational study

Baker¹,

Gilmore²,

Chen³

et al. 2023

Research and Practice in Thrombosis and Haemostasis

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Section: Discussionmentioning

confidence: 99%

Direct oral anticoagulants or vitamin K antagonists in emergencies: comparison of management in an observational study

Baker¹,

Gilmore²,

Chen³

et al. 2023

Research and Practice in Thrombosis and Haemostasis

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“… 56 – 58 The Anti-Xa is standardizable, reproducible and readily implementable in facilities that already use this methodology to monitor for heparin therapy. 50 , 59 Compared to the PT and aPTT, Anti-Xa provides better consistent and reliable anticoagulation monitoring for patients with hepatic impairment, 60 or patients with isolated prolonged PT or aPTT.…”

Section: Challenge #2: Can We Standardize Testing For Doac Monitoring?mentioning

confidence: 99%

“… 61 In addition, there is a need for drug-specific calibrators, adding complexity to test implementation and clinician familiarity, especially in settings with limited resources. 59 , 62 The requirements of additional cost and laboratory expertise may limit widespread implementation and use in all clinical settings on a 24/7 basis. 63 Best practice incentives to reduce cost and/or educate both physicians and clinical laboratory scientists may help overcome implementation barriers.…”

Section: Challenge #2: Can We Standardize Testing For Doac Monitoring?mentioning

confidence: 99%

Challenges to Laboratory Monitoring of Direct Oral Anticoagulants

Qiao,

Tran

2024

Clin Appl Thromb Hemost

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Direct oral anticoagulants (DOACs) exert anticoagulation effect by directly inhibiting Factor Xa (rivaroxaban, apixaban, and edoxaban) or thrombin (dabigatran). Though DOACs are characterized by fixed-dose prescribing and generally do not require routine laboratory drug-level monitoring (DLM), circumstances may arise where the DLM may aid in clinical decision-making, including DOAC dose adjustment, anticoagulant class change, or decisions to withhold or administer reversal agents. We review the current literature that describes high-risk patient groups in which DLM may be beneficial for improved patient anticoagulation management and stewardship. The review also summarizes the limitations of conventional coagulation testing and discuss the emerging utility of quantitative methods for routine and rapid emergent evaluation of DOAC drug levels—in particular, the Anti-Xa activity to detect Factor Xa Inhibitors (rivaroxaban, apixaban, and edoxaban). Both technical and regulatory barriers to widespread DLM implementation are limiting factors to further clinical research that must be overcome, in order to propose universal DOAC DLM strategies and provide clinical-laboratory correlation to formally classify high-risk patient groups.

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“…The TT is highly sensitive to dabigatran levels and although a normal TT can exclude the presence of dabigatran, the TT cannot be reliably used to estimate or measure drug concentration unless the test is modified 27 . Anti‐Xa testing using LMWH calibration curves can provide both an indication of FXa DOAC presence and, if properly assessed by the laboratory, can be used to estimate direct FXa inhibitor anticoagulant intensity, although difference between kits were noted 26–29 . Therefore, TT and anti‐FXa could be used to indicate DOAC presence or absence if drug‐specific testing is not locally available.…”

Section: What Is the Role Of The Laboratory In Doac Therapy?mentioning

confidence: 99%

“… 27 Anti‐Xa testing using LMWH calibration curves can provide both an indication of FXa DOAC presence and, if properly assessed by the laboratory, can be used to estimate direct FXa inhibitor anticoagulant intensity, although difference between kits were noted. 26 , 27 , 28 , 29 Therefore, TT and anti‐FXa could be used to indicate DOAC presence or absence if drug‐specific testing is not locally available. This information may be of value in emergent cases where clinical history is not readily available and acute intervention is required (e.g., trauma, surgery, acute stroke).…”

Section: What Is the Role Of The Laboratory In Doac ...mentioning

confidence: 99%

The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization

Gosselin

Favaloro

Douxfils

2022

Journal of Thrombosis and Haemostasis

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For more than a decade, US laboratories have failed to implement solutions to help their clinicians in managing complex situations or patients on direct oral anticoagulants (DOACs). The problem may find different origins, among which is the position of the Food and Drug Administration, which categorized these drugs as monitoring‐ and measurement‐free, whereas other regulatory bodies like the European Medicines Agency or the Therapeutic Goods Administration in Australia were more conservative on the principle that the absence of proof (of monitoring/measurement benefits) is not proof of an absence (of monitoring/measurement needs). Pivotal clinical studies that led to the approval of DOACs were presented as devoid of such testing, although some companies considered monitoring as a solution to improve their benefit/risk ratio. In this JTH In Clinics issue, we report more than a decade of development that has permitted the activation of smart laboratory solutions to qualify or quantify DOACs and discuss myths and misconceptions around technical and regulatory requirements that support the current reluctance of implementing these technologies in most US laboratories. Use of DOACs is ever expanding, with DOAC prescriptions now exceeding those of other anticoagulants, including vitamin K antagonists, in some geographies. As this use increases, the likely need to measure DOAC exposure will also increase. Measurement of DOACs does not represent any technical difficulty. That these laboratory tests are not available in some locations suggests disparities in patient care, and we suggest it is time to address such inequalities.

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Prospective cohort study on the use of low molecular weight heparin calibrated anti-Xa assay for measurement of direct oral Xa inhibitors in ex vivo patient samples

Cited by 5 publications

References 23 publications

Direct oral anticoagulants or vitamin K antagonists in emergencies: comparison of management in an observational study

Direct oral anticoagulants or vitamin K antagonists in emergencies: comparison of management in an observational study

Challenges to Laboratory Monitoring of Direct Oral Anticoagulants

The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization

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