Dabigatran etexilate is an oral, reversible direct thrombin inhibitor that is 
approved in the EU and several other countries for the prevention of venous 
thromboembolism after elective hip and knee replacement, and is in advanced 
clinical development for other thromboembolic disorders. Dabigatran has a 
predictable pharmacokinetic profile, allowing for a fixed-dose regimen without 
the need for routine coagulation monitoring. In certain clinical situations such 
as serious bleeding into critical organs (e.g. intracerebral bleeding), 
potential overdose and emergency surgery, clinicians will need to make an 
assessment of the anticoagulant status of a patient receiving dabigatran before 
deciding on future management strategies. If available, thrombin clotting time 
(TT), ecarin clotting time (ECT) and TT determined by Hemoclot thrombin 
inhibitor assay are sensitive tests to evaluate the anticoagulant effects of 
dabigatran. Prothrombin time (INR) is less sensitive than other assays and 
cannot be recommended. The activated partial thromboplastin time (aPTT) can 
provide a useful qualitative assessment of anticoagulant activity but is less 
sensitive at supratherapeutic dabigatran levels. There are limited data for 
activated clotting time (ACT). Overall, the aPTT and TT are the most accessible 
qualitative methods for determining the presence or absence of anticoagulant 
effect. Although there is no specific antidote to antagonise the anticoagulant 
effect of dabigatran, due to its short duration of effect drug discontinuation 
is usually sufficient to reverse any excessive anticoagulant activity. In case 
of potential overdose, the feasibility of early administration of activated 
charcoal and subsequent charcoal filtration are undergoing preclinical 
evaluation. Dabigatran can also be dialysed in patients with renal impairment. 
In instances of life-threatening bleeding, where conventional measures have 
failed or are unavailable, other non-specific prohaemostatic agents such as 
recombinant activated factor VII and prothrombin complex concentrates can be 
considered.