Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
- Conditions
- Anticoagulant Therapy
- Interventions
- Registration Number
- NCT05491460
- Lead Sponsor
- Doasense GmbH
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
-
Fully signed and dated written informed consent
- Age >18 years
- healthy
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apixaban Apixaban 5 MG Tab Volunteers receive one oral dose of 5mg Apxiaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured. Dabigatran Dabigatran 150 MG Tab Volunteers receive one oral dose of 150mg Dabigatran followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured. Rivaroxaban Rivaroxaban 20 MG Tab Volunteers receive one oral dose of 20mg Rivaroxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured. Edoxaban Edoxaban 60Mg Tab Volunteers receive one oral dose of 60mg Edoxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Clincial Research Serivces
🇩🇪Mannheim, Germany