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

This study has been completed.
Information provided by (Responsible Party):
Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien Identifier:
First received: June 5, 2012
Last updated: April 4, 2017
Last verified: April 2017

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.

Effect of NOAC on POCT

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Time-dependent ex Vivo Influence of Rivaroxaban on Point-of-care Devices

Resource links provided by NLM:

Further study details as provided by Cardioangiologisches Centrum Bethanien:

Enrollment: 100
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Healthy volunteers without medication
Patients receiving Marcumar having target INR 2-3
Patients receiving therapeutic dosis of Pradaxa
Patients receiving therapeutic dosis of Xarelto

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

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
Study First Received: June 5, 2012
Last Updated: April 4, 2017

Keywords provided by 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
Anticoagulants processed this record on April 26, 2017