Clincosm LogoSign in Get a demo

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

Sponsor
Cardioangiologisches Centrum Bethanien (Other)
Overall Status
Completed
CT.gov ID
NCT01613443
Collaborator
(none)
100
Enrollment
14
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jun 1, 2012
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Healthy volunteers without medication
    Phenprocoumon

    Patients receiving Marcumar having target INR 2-3
    Dabigatran

    Patients receiving therapeutic dosis of Pradaxa
    Rivaroxaban

    Patients receiving therapeutic dosis of Xarelto

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      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

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Cardioangiologisches Centrum Bethanien

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Prof. Dr. med. E. Lindhoff-Last, Prof. Dr. med. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
      ClinicalTrials.gov Identifier:
      NCT01613443
      Other Study ID Numbers:
      • POCT-NOAC
      First Posted:
      Jun 7, 2012
      Last Update Posted:
      Apr 5, 2017
      Last Verified:
      Apr 1, 2017
      Keywords provided by Prof. Dr. med. E. Lindhoff-Last, Prof. Dr. med. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
      Dabigatran, Rivaroxaban, Point of Care-testing

      Study Results

      No Results Posted as of Apr 5, 2017