Specific PoC Testing of Coagulation in Patients Treated With DOAC 1
- Conditions
- Anticoagulation With NOAC
- Interventions
- Other: ecarin clotting time point-of-care testing (ECT-POCT)Other: anti-Xa activity point-of-care testing (aXa-POCT)
- Registration Number
- NCT02825394
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description dabigatran on-treatment ecarin clotting time point-of-care testing (ECT-POCT) N=20 apixaban on-treatment anti-Xa activity point-of-care testing (aXa-POCT) N=20 rivaroxaban initiation anti-Xa activity point-of-care testing (aXa-POCT) N=20 rivaroxaban on-treatment anti-Xa activity point-of-care testing (aXa-POCT) N=20 edoxaban initiation anti-Xa activity point-of-care testing (aXa-POCT) N=20 edoxaban on-treatment anti-Xa activity point-of-care testing (aXa-POCT) N=20 apixaban initiation anti-Xa activity point-of-care testing (aXa-POCT) N=20 dabigatran initiation ecarin clotting time point-of-care testing (ECT-POCT) N=20
- Primary Outcome Measures
Name Time Method Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result 24 hours DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
- Secondary Outcome Measures
Name Time Method Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay 24 hours 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 edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay 24 hours Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) 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
Trial Locations
- Locations (1)
University Hospital Tuebingen
🇩🇪Tuebingen, Germany