Anticoagulation With Direct Oral Anticoagulants
Conditions
Brief summary
The investigators study aims to test the correlation between the Hemochron Signature point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.
Interventions
None listed
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
* Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events * Age ≥ 18 years
Exclusion criteria
* Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation * Low-molecular weight heparin ≤ 24 hours * Unfractionated heparin ≤ 12 hours * Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.) * History of coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect/Correlation of direct oral anticoagulants (DOAC) on Hemochron Signature point-of-care testing (POCT) result | 24 hours | DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry |
Secondary
| Measure | Time frame |
|---|---|
| Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay | 24h |
| Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels | 24h |
Outcome results
None listed