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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613443
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Prof. Dr. med. E. Lindhoff-Last, 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.

Condition or disease
Effect of NOAC on POCT

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 Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Time-dependent ex Vivo Influence of Rivaroxaban on Point-of-care Devices
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Rivaroxaban

Healthy volunteers without medication
Patients receiving Marcumar having target INR 2-3
Patients receiving therapeutic dosis of Pradaxa
Patients receiving therapeutic dosis of Xarelto

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for NOAC-therapy

The indication for the use of NOAC is provided by the attending physician. The criteria for inclusion and exclusion criteria for the use of the new oral anticoagulants must meet appropriate eligibility criteria and the clinical guidelines that are described in the SOPs.

Patients treated with dabigatran 2x150mg / d for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation are included.

Moreover, patients treated with rivaroxaban 20 mg / d for DVT prophylaxis and treatment of recurrent DVT or PE are included.

Publications of Results:
Responsible Party: Prof. Dr. med. E. Lindhoff-Last, Prof. Dr. med. Lindhoff-Last, Cardioangiologisches Centrum Bethanien Identifier: NCT01613443     History of Changes
Other Study ID Numbers: POCT-NOAC
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien:
Dabigatran, Rivaroxaban, Point of Care-testing

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action