Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2
Completed
- Conditions
- Anticoagulation With Direct Oral Anticoagulants
- Registration Number
- NCT02371070
- Lead Sponsor
- University Hospital Tuebingen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels 24h Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay 24h