Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

• Status: Active, not recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Doasense GmbH
• Treatments: Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Criteria

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.