Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study

August 14, 2014 updated by: Dr. Matthias Klages, Johann Wolfgang Goethe University Hospital

Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer

The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate).

Study Overview

Status

Completed

Conditions

Detailed Description

Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will be taken twice in correlation to the time of drug intake (before and 3 hours after drug intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer will be compared directly with the concentrations determined by plasma concentration assays.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt/Main, Hessen, Germany, 60590
        • University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran or Rivaroxaban for prevention of stroke and systemic embolism.

Description

Inclusion Criteria:

  • Patients receiving Dabigatran or Rivaroxaban
  • Adults > 18 years

Exclusion Criteria:

  • Patients receiving concomittantly inhibitors of platelet function
  • Renal insufficiency (Creatinine > 1,5 mg/dl), Urea > 80 mg/dl)
  • Hemodialysis
  • Hepatic Dysfunction (AST > 30 U/l, ALT > 30 U/l)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NOAPOC-271/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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