We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704053
First Posted: October 11, 2012
Last Update Posted: August 15, 2014
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.
Information provided by (Responsible Party):
Dr. Matthias Klages, Johann Wolfgang Goethe University Hospitals
  Purpose
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).

Condition
Clot Formation and Platelet Aggregation in Point of Care Testing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer

Resource links provided by NLM:


Further study details as provided by Dr. Matthias Klages, Johann Wolfgang Goethe University Hospitals:

Enrollment: 34
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704053


Locations
Germany
University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
Frankfurt/Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Dr. Matthias Klages, M.D., Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01704053     History of Changes
Other Study ID Numbers: NOAPOC-271/12
First Submitted: October 8, 2012
First Posted: October 11, 2012
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by Dr. Matthias Klages, Johann Wolfgang Goethe University Hospitals:
New Oral Anticoagulants
Dabigatran
Rivaroxaban
Thrombelastometry/-graphy (ROTEM, TEG)
Multiple Platelet Function Analyzer (Multiplate)

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