Anticoagulation With NOAC
Conditions
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.
Interventions
OTHERanti-Xa activity point-of-care testing (aXa-POCT)
OTHERecarin clotting time point-of-care testing (ECT-POCT)
Sponsors
Heart and Diabetes Center North Rhine-Westphalia
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels | 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 |
| Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay | 24 hours |
Countries
Germany
Contacts
Primary ContactSven Poli, MD MSc
Backup ContactFlorian Härtig, MD
Outcome results
None listed