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

Completed

• Conditions: Effect of NOAC on POCT

• Registration Number: NCT01613443
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

Brief 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified