Dabigatran Falsely Elevates Point of Care International Normalized Ratio Results

DeRemer, Christina E.; Gujral, Jaspal S; Thornton, John W.; Sorrentino, Robert

doi:10.1016/j.amjmed.2011.02.009

Cited by 22 publications

(14 citation statements)

References 2 publications

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“…With the exception of a few case reports that have demonstrated elevated POC International Normalized Ratio results in patients on dabigatran, and in vitro drug‐spiking in whole blood from healthy volunteers, no data have previously been published on the performance of whole blood POC coagulation analyzers . Our study investigated POC PT, APTT and ACT using the HEMOCHRON ® Signature Elite whole blood coagulation device.…”

Section: Discussionmentioning

confidence: 99%

“…Information on ex vivo data from patients treated with dabigatran is limited, owing to the use of doses other than 150 mg twice daily, lack of reporting of detailed data, testing of only one reagent for a particular coagulation assay, and evaluation of coagulation response in patients enrolled into pharmaceutical company‐sponsored studies with strict enrollment exclusion criteria . Very limited information exists on the performance of point‐of‐care (POC) coagulation assays in dabigatran‐treated patients .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross‐sectional pharmacodynamic study based on peak and trough plasma levels

Hawes

Deal²,

Funk-Adcock³

et al. 2013

Journal of Thrombosis and Haemostasis

189

206

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S. Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross-sectional pharmacodynamic study based on peak and trough plasma levels. J Thromb Haemost 2013; 11: 1493-1502.Summary. Background: Knowledge of anticoagulation status during dabigatran therapy may be desirable in certain clinical situations. Objective: To determine the coagulation tests that are most useful for assessing dabigatran's anticoagulant effect. Methods: Peak and trough blood samples from 35 patients taking dabigatran 150 mg twice daily, and one sample each from 30 non-anticoagulated individuals, were collected. Mass spectrometry and various coagulation assays were performed. 'Therapeutic range' was defined as the range of plasma dabigatran concentrations determined by mass spectrometry between the 2.5th and 97.5th percentiles of all values. Results: The therapeutic range was 27-411 ng mL À1. The prothrombin time (PT) and activated partial thromboplastin time (APTT), determined with multiple reagents, and activated clotting time (ACT) were insensitive to therapeutic dabigatran: 29%, 18% and 40% of samples had a normal PT, APTT, and ACT, respectively. However, normal PT, ACT and APTT ruled out dabigatran levels above the 75th percentile. The thrombin clotting time (TCT) correlated well and linearly with dabigatran levels below the 50th percentile, but was unmeasurable above it. The dilute thrombin time, ecarin clotting time and ecarin chromogenic assay showed linear correlations with dabigatran levels over a broad range, and identified therapeutic and supratherapeutic levels. Conclusions: The prothrombin time, APTT and ACT are often normal in spite of therapeutic dabigatran plasma levels. The TCT is useful for detecting minimal dabigatran levels. The dilute thrombin time and chromogenic and clotting ecarin assays accurately identify therapeutic and supratherapeutic dabigatran levels. This trial is registered at www.clinicaltrials.gov (#NCT01588327).

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross‐sectional pharmacodynamic study based on peak and trough plasma levels

Hawes

Deal²,

Funk-Adcock³

et al. 2013

Journal of Thrombosis and Haemostasis

189

206

View full text Add to dashboard Cite

show abstract

“…Dabigatran prolongs the PT, often reported as an INR, in a concentration‐dependent manner, but the effect is minimal with dabigatran concentrations up to 200 ng mL −1 (expected drug exposure: 50–300 ng mL −1 ), with INR values ranging from 0.9 to 1.2 [15]. In addition, INR determinations performed at the point of care in dabigatran‐treated patients can differ from those performed in central laboratories [16–18]. Although INR values are elevated with high concentrations of dabigatran, substantial differences are noted, depending on the thromboplastin reagent used to perform the test [15].…”

Section: Assessment Of the Anticoagulant Effects Of The New Oral Antimentioning

confidence: 99%

Laboratory assessment of the anticoagulant effects of the next generation of oral anticoagulants

García

Barrett

Ramacciotti

et al. 2013

Journal of Thrombosis and Haemostasis

111

119

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Summary. In contrast to vitamin K antagonists, which reduce the functional levels of several coagulation factors, the new oral anticoagulants specifically target either thrombin or factor Xa. These new agents have such predictable pharmacokinetics and pharmacodynamics that routine coagulation monitoring is unnecessary. However, there are still some situations in which measurement of anticoagulant effect may be required. The coagulation assays that are used to monitor heparin derivatives or vitamin K antagonists may not always accurately reflect the anticoagulant activity of the new oral anticoagulants, and specialized assays may be needed. In this article, we: (i) identify situations in which assessment of anticoagulant effect may aid treatment decisions; (ii) describe the effects of the new oral anticoagulants on the various coagulation tests; (iii) review the specialized coagulation assays that have been developed to measure the anticoagulant effects of the new oral anticoagulants; and (iv) provide a clinical perspective on the role of coagulation testing in the clinical management of patients treated with the new oral anticoagulants.

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“…10 Dabigatran also rarely causes false elevations of the INR, which has the potential to adversely affect patient care. 11 The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial showed that dabigatran, at a dose of 150mg twice daily, compared to dose-adjusted warfarin was associated with lower rates of stroke and systemic embolism but similar rates of major bleeding. 7 The trial also noted an increase in the rate of MI in patients receiving dabigatran.…”

Section: Discussionmentioning

confidence: 99%

Acute Myocardial Infarction after Switching from Warfarin to Dabigatran

Abuzeid¹,

Al-Lawati²,

Fam³

2015

Oman Med J

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Dabigatran etexilate is a recently approved direct thrombin inhibitor (DTI), which is superior to warfarin in the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). However, dabigatran use is associated with an increased risk of myocardial infarction (MI) compared to warfarin. The mechanisms for this association effect remain speculative. We present a case of an acute MI and cardiac arrest in a patient with chronic AF who had been recently switched from warfarin to dabigatran. Urgent coronary angiography, at St. Michael's hospital (Toronto, Canada), revealed evidence of thromboembolism to the distal posterior descending artery. The patient was treated medically and switched back from dabigatran to warfarin. He did well and was discharged after an uneventful stay in the coronary care unit.

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Dabigatran Falsely Elevates Point of Care International Normalized Ratio Results

Cited by 22 publications

References 2 publications

Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross‐sectional pharmacodynamic study based on peak and trough plasma levels

Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross‐sectional pharmacodynamic study based on peak and trough plasma levels

Laboratory assessment of the anticoagulant effects of the next generation of oral anticoagulants

Acute Myocardial Infarction after Switching from Warfarin to Dabigatran

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