Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

Study Overview
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Brief Summary
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The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.

Official Title
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Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1

Conditions
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Anticoagulation With NOAC

Intervention / Treatment
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* Other: anti-Xa activity point-of-care testing (aXa-POCT)
* Other: ecarin clotting time point-of-care testing (ECT-POCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban Age ≥ 18 years Written informed consent by patient Exclusion Criteria: Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation Part A only: abnormal routine coagulation test values at baseline (defined by INR > 1.2, Quick < 70% or aPTT > 40 sec) History of coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| apixaban initiation<br>N=20 | Other: anti-Xa activity point-of-care testing (aXa-POCT)<br> <br> * Other names: Cascade Abrazo with ENOX and ENOX LR test cards;|
| apixaban on-treatment<br>N=20 | Other: anti-Xa activity point-of-care testing (aXa-POCT)<br> <br> * Other names: Cascade Abrazo with ENOX and ENOX LR test cards;|
| dabigatran initiation<br>N=20 | Other: ecarin clotting time point-of-care testing (ECT-POCT)<br> <br> * Other names: Cascade Abrazo with DTM test cards;|
| dabigatran on-treatment<br>N=20 | Other: ecarin clotting time point-of-care testing (ECT-POCT)<br> <br> * Other names: Cascade Abrazo with DTM test cards;|
| rivaroxaban initiation<br>N=20 | Other: anti-Xa activity point-of-care testing (aXa-POCT)<br> <br> * Other names: Cascade Abrazo with ENOX and ENOX LR test cards;|
| rivaroxaban on-treatment<br>N=20 | Other: anti-Xa activity point-of-care testing (aXa-POCT)<br> <br> * Other names: Cascade Abrazo with ENOX and ENOX LR test cards;|
| edoxaban initiation<br>N=20 | Other: anti-Xa activity point-of-care testing (aXa-POCT)<br> <br> * Other names: Cascade Abrazo with ENOX and ENOX LR test cards;|
| edoxaban on-treatment<br>N=20 | Other: anti-Xa activity point-of-care testing (aXa-POCT)<br> <br> * Other names: Cascade Abrazo with ENOX and ENOX LR test cards;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result | DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels |  | 24 hours | 
| Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay |  | 24 hours | 
| Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay |  | 24 hours | 
| Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay |  | 24 hours | 
| Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay |  | 24 hours | 
| Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay |  | 24 hours | 
| Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay |  | 24 hours | 
| Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay |  | 24 hours | 
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay |  | 24 hours | 
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay |  | 24 hours | 
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay |  | 24 hours | 
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay |  | 24 hours |