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Clear
 
Test Code:
090-10-1150

Order Name:
Dabigatran Level (Pradaxa)

 
Useful For:
Measuring dabigatran concentration in plasma.
 
This assay is not useful for measurement of other direct thrombin inhibitors eg, argatroban or bivalirudin.
 
Methodology:
Direct Thrombin Inhibitor assay
 
AliasesName:
DABIGATRAN
Pradaxa
 
 
 
Test Code:
090-10-1150

Order Name:
Dabigatran Level (Pradaxa)

 
Collection Specimen Or Container:
Blood/ Sodium citrate tube (Sodium Citrate 3.2% anticoagulant, Blue top) 3 mL, 1 tube
 
Specimen Testing Type:
Citrate plasma, minimum volume 1 mL
Freeze plasma immediately (no longer than 4 hours after collection) at -20oC
 
Sub Mission Container:
Plastic tube
 
Rejection Criteria:
Hemolysis: Hemoglobin > 300 mg/dL will be reject.
Lipemia: Triglyceride > 873 mg/dL will be reject.
Icterus: Bilirubin > 40 mg/dL will be reject.
Other:
     1.  Clotted specimen will be reject.
     2.  In patients receiving heparin for therapeutic purposes. Blood should not be drawn from a heparin catheter.
 
Specimen Stabillity:
Specimen type Temperature Time
Platelet-poor plasma Room temperature, 18oC - 24oC 1 hour
Refrigerated, 2oC to 8oC 4 hours
 
 
 
Test Code:
090-10-1150

Order Name:
Dabigatran Level (Pradaxa)

 
Method detail:
Direct Thrombin Inhibitor assay
 
Schedule:
Tested daily (24 hours)
 
Turnaround Time:
Collected specimen to report within 2 hours
 
Performing Location:
Hematology, Laboratory Department, Tel. 13225
 
Specimen Retention Time:
14 days
 
 
 
Test Code:
090-10-1150

Order Name:
Dabigatran Level (Pradaxa)

 
 
Clinical Information:
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.
 
Reference Value:
1.  For stroke prevention in non-valvular atrial fibrillation
     -  Peak concentration: 117-275 ng/mL
     -  Trough concentration: 61-143 ng/mL

2.  For treatment PE/VTE
     -  Peak concentration: 117-275 ng/mL
     -  Trough concentration: 39-95 ng/mL
 
Interpretation:
See Clinical Information for peak and trough drug concentrations observed in clinical trials of dabigatran.
 
Clinical Reference:
  1. Manufacturer’s reagent package insert, Direct Thrombin Inhibitor Assay, HemosIL®, Instrumentation Laboratory Company - Bedford, MA 01730-2443 (USA), Instrumentation Laboratory SpA - V.le Monza 338 - 20128 Milano (Italy), 11/2016
  2. https://www.mayocliniclabs.com (Retrieved: 15 Nov 2020)