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Determination of dabigatran in human plasma samples
Job Harenberg1, Christina Giese, Svetlana Marx
1Department of Clinical Pharmacology, Medical Faculty, Mannheim, Ruprecht-Karls-University Heidelberg, Maybachstrasse, Mannheim, Germany. job.harenberg@medma.uni-heidelberg.de
Seminars in Thrombosis and Hemostasis
|February 9, 2012
Summary
Dabigatran, a direct thrombin inhibitor, effectively prevents thromboembolism. Measuring its anticoagulant effect using routine assays is useful in special patient groups to check for overdose or compliance issues.
Area of Science:
- Pharmacology
- Hematology
- Clinical Chemistry
Background:
- Dabigatran is an oral direct thrombin inhibitor used for thromboembolism prevention.
- It is primarily renally eliminated (approximately 80%).
- Fixed dosing is standard, but monitoring may be needed in specific populations.
Purpose of the Study:
- To evaluate the impact of dabigatran on clinical routine coagulation assays.
- To assess the utility of these assays for monitoring dabigatran in special patient populations.
- To investigate the potential for detecting overdose or non-compliance.
Main Methods:
- Review of existing literature on dabigatran's pharmacokinetics and pharmacodynamics.
- Analysis of how dabigatran affects various in vitro clotting and chromogenic substrate assays.
- Discussion of clinical scenarios requiring dabigatran level determination.
Main Results:
- Dabigatran prolongs the results of multiple routine coagulation and specific thrombin assays.
- These assays show measurable changes in the presence of dabigatran.
- The degree of prolongation correlates with dabigatran concentration.
Conclusions:
- Clinical routine assays can reflect the in vitro anticoagulant activity of dabigatran.
- These assays may be valuable for assessing dabigatran levels in elderly patients, those with renal impairment, or when overdose/non-compliance is suspected.
- Monitoring dabigatran's effect is beneficial in specific clinical situations.
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