Dear Peter,

We use standard Stago Thrombin time to demonstrate Dabigatran, this test is very sensitive of course but it is still useful to demonstrate either patient compliance or total clearance of the drug. To differentiate Dabigatran from unfractionated heparin we repeat the TCT with the addition of Protamine sulphate.

We are occasionally required to perform an assay for Dabigatran, we use a in-house modified TCT similar to the Hemoclot method  but using reagents that are onboard our analyser 24/7. We use Hyphen Biomed Calibrators and Controls. The assay is essentially a Thrombin time where the patient sample is diluted then mixed with normal plasma then clotted with Thrombin. The assay appears stable and reliable and performs well in EQA.

Another option is the Ecarin time which has a good linear sensitivity to Dabigatran however the thrombin based methods were more appealing to us because of the easy availability and lot to lot consistency.

Regards,

Simon Jones

We also use in-house modified thrombin time with Hyphen Biomed Calibrators and Controls (data in the attached article). We have protocols for CS2100i and BCS analyzers.

Article Diluted thrombin time reliably measures low to intermediate ...

The Dabigatran etexilate is a reversible direct thrombin inhibitor that is administered orally, is indicated 2 times a day and the maximum activity of the drug is achieved between 1-2 hours post ingestion. The concentrations achieved in 1-4 hours (peak) are much higher than those found in the valley (before the next intake).

I use a test coagulometric, HemosIL DTI, Instrumentation Laboratory (IL) using bovine thrombin and normal plasma as the diluent.

The calibrators and controls are provided by the manufacturer.

The drug has an extended linear range in 0-493ng / mL range, which was calculated in our laboratory and a very low detection limit, HemosIL DTI analysis with dabigatran calibrators and controls offers unparalleled technical performance for major laboratories hemostasis. This allows us to perform regular and accurate solutions to critical situations. Like other analysis HemosIL, DTI is automated on the menu offered by ACL / TOP systems that are exceptional efficiency ..

The new analysis DTI meet critical needs, providing essential for patient management tool and meets our responsiveness and dynamic healthcare environment.

There are exceptions where the extent where it may be advantageous to include patients who present in the emergency room an adverse event requiring immediate reversal of anticoagulation, or kidney or liver function insufficient .It should have known interactions with other drugs or request verification of clearance of drugs preoperatively. 

All plasmatic anticoagulants should be monitored by the same assay. This allows comparison of them. An ultra-specific factor 10a/thrombin generation assay (such as EXCA or INCA) would be the ideal routine test.