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Test Catalog

Test ID: DABIE    
Dabigatran, Ecarin, Plasma

Useful For Suggests clinical disorders or settings where the test may be helpful

Measuring dabigatran concentration in plasma

 

This assay is not useful for measurement of other direct thrombin inhibitors eg, argatroban or bivalirudin.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Dabigatran, an oral direct thrombin inhibitor (DTI) that directly inhibits factor IIa, is indicated for use in patients with nonvalvular atrial fibrillation and venous thromboembolism. Dabigatran is administered orally twice daily, is eliminated primarily through the renal system, and can inhibit both soluble and clot-bound thrombin. Dabigatran does not require routine therapeutic monitoring. However, in selected clinical situations, measurement of drug level would be useful, eg, renal insufficiency, assessment of compliance, periprocedural, suspected overdose, advanced age, and extremes of body weight.

 

Observed dabigatran steady-state exposure concentrations

Nonvalvular atrial fibrillation(1)

Median trough levels

(10-16 hours post dose)

Median peak levels

(1-3 hours post dose)

110 mg twice daily

64.7 ng/mL (28.2-155)

126 ng/mL (52-275)

150 mg twice daily

91 ng/mL (39.8-215)

175 ng/mL (74.3-383)

 

Venous thromboembolism(2)

Median trough levels

(10-16 hours post dose)

 

150 mg twice daily

59.7 ng/mL (38.6-146)

 

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<20 ng/mL

Interpretation Provides information to assist in interpretation of the test results

Therapeutic reference ranges have not been established. See Clinical Information for peak and trough drug concentrations observed in clinical trials of dabigatran.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Dabigatran concentration may be affected by drug interactions as well as liver and renal disease.

 

Marked presence of lipemia or bilirubin in the sample could falsely decrease dabigatran levels.

Supportive Data

The lower limit of detection of this assay is 20 ng/mL.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Reilly PA, Lehr T, Haertter S, et al: The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial. Am J Coll Cardiol. 2014;63:321-328

2. Pradaxa (dabigatran etexilate). Public Assessment Record. European Medicines Agency; 2008 Update January 23, 2020. Accessed June 19, 2020. Available at www.ema.europa.eu/en/medicines/human/EPAR/pradaxa

3. Van Cott EM, Roberts AJ, Dager WE: Laboratory monitoring of parenteral direct thrombin inhibitors. Semin Thromb Hemost. 2017;43: 270-276

4. Gosselin RC, King JH, Janatpour KA, et al: Comparing direct thrombin inhibitors using aPTT, Ecarin clotting times, and thrombin inhibitor management testing. Ann Pharmacother. 2004;38:1383-1388

5. Gosselin RC, Adcock DM, Bates SM, et al: International Council for Standardization in Haematology (ICSH) recommendations for laboratory measurement of direct oral anticoagulants. Thromb Haemost. 2018 Mar;118(3):437-450

6. Lind SE, Boyle ME, Fisher S, Ishimoto J, Trujillo TC, Kiser TH: Comparison of the aPTT with alternative tests for monitoring direct trombin inhibitors in patient samples. Am J Clin Pathol. May 2014;141:665-674

7. Curvers J, van de Kerkhof D, Stroobants AK, van den Dool EJ, Scharnhorst V: Measuring direct thrombin inhibitors with routine and dedicated coagulation assays.  Am J Clin Pathol. 2012;138: 551-558

8. Fenyvesi T, Jorg I, Harenberg J: Monitoring of anticoagulant effects of direct thrombin inhibitors. Semin Thromb Hemost. 2002;28(4):361-368

9. PRADAXA (dabigatran etexilate). Package insert: Boehringer Ingelheim Pharmaceuticals, Inc; 2019

Special Instructions Library of PDFs including pertinent information and forms related to the test