NCT01613443

Ex-vivo Effect of New Oral Anticoagulants on Point-of-care Devices

Time-dependent ex Vivo Influence of Rivaroxaban on Point-of-care Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Cardioangiologisches Centrum Bethanien · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Concentration determinations of anticoagulants require plasma instead of whole blood, and results are not immediately available to clinicians. Monitoring anticoagulants concentration along with bedside methods may provide an alternative guide for administration of the NOAC. The purpose of this investigation is to compare bedside coagulation assays in whole blood with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with therapeutic dosis of NOAC.

Detailed description

This open-label study will be performed by ex vivo investigations. Patients receiving the NOAC as dabigatran or rivaroxaban in therapeutic doses are recruited and informed consent of two blood sampling times will be obtained in correlation to the time of drug intake (two and 24 hours after drug intake). The bedside measurements will be performed and compared directly with the concentrations determined by plasma concentration assays. These investigations will be performed at the department of Angiology at the university hospital Frankfurt.

Conditions

• Effect of NOAC on POCT

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-08-01
• First posted: 2012-06-07
• Last updated: 2024-03-12