Anticoagulant Therapy
Conditions
Keywords
anticoagulant, direct oral anticoagulant, apixaban, edoxaban, rivaroxaban, dabigatran, coagulation, point of care method
Brief summary
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time \[PT\] and activated partial thromboplastin time \[aPTT\]) from plasma samples show a high variation. Special coagulation tests like hemoclot for dabigatran and chromogenic substrate assays for Rivaroxaban, Apixaban, and Edoxaban are time-consuming and can be performed only in specialized laboratories. In specific medical situations like in patients such as emergency procedures, stroke (before starting thrombolytic therapy), trauma, general surgery or other invasive procedures, it may be necessary for medical decision making to know the presence or absence of a DOAC in patient's body fluid. Until now there is no rapid, specific and sensitive coagulation test available in the market.
Detailed description
This prospective, open-label, controlled, not randomized trial in healthy volunteers to investigate comparatively the pharmacokinetics of the direct oral anticoagulants in plasma and in urine with LC-MS/MS and in urine by DOAC Dipstick.
Interventions
DRUGApixaban 5 MG Tab
oral intake
DRUGDabigatran 150 MG Tab
oral intake
DRUGEdoxaban 60Mg Tab
oral intake
DRUGRivaroxaban 20 MG Tab
oral intake
Sponsors
Doasense GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Fully signed and dated written informed consent * Age \>18 years * healthy
Exclusion criteria
* Patients not able to provide urine samples. * Patients not able to understand the informed consent or severe mentally disabled. * Patients in the end-stage of a severe disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS | up to 6 months | Assess the accuracy and specificity of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients True positive and true negative rate of the point of care test (POCT) by comparison with the results obtained by bioanalytical quantification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of qualitative POCT with quantitative LC-MS/MS | up to 6 months | Comparison of qualitative POCT with quantitative LC-MS/MS Investigator readings of POCT test results as compared to LC-MS/MS |
| Questionnaire on handling and usability | up to 6 months | Specific questions to be answered using Lickert scale by personal performing the test |
Countries
Germany
Outcome results
None listed