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

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: NCT01704053
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):
Dr. Matthias Klages, Johann Wolfgang Goethe University Hospital

Brief Summary:
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 or disease
Clot Formation and Platelet Aggregation in Point of Care Testing

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.

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Study Type : Observational
Actual Enrollment : 34 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

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

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

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)

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 identifier (NCT number): NCT01704053

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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

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Responsible Party: Dr. Matthias Klages, M.D., Johann Wolfgang Goethe University Hospital Identifier: NCT01704053    
Other Study ID Numbers: NOAPOC-271/12
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Dr. Matthias Klages, Johann Wolfgang Goethe University Hospital:
New Oral Anticoagulants
Thrombelastometry/-graphy (ROTEM, TEG)
Multiple Platelet Function Analyzer (Multiplate)