Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study
This study has been completed.
Information provided by (Responsible Party):
Dr. Matthias Klages, Johann Wolfgang Goethe University Hospitals
First received: October 8, 2012
Last updated: August 14, 2014
Last verified: August 2014
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).
Clot Formation and Platelet Aggregation in Point of Care Testing
||Observational Model: Case Control
Time Perspective: Prospective
||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:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran or Rivaroxaban for prevention of stroke and systemic embolism.
- Patients receiving Dabigatran or Rivaroxaban
- Adults > 18 years
- Patients receiving concomittantly inhibitors of platelet function
- Renal insufficiency (Creatinine > 1,5 mg/dl), Urea > 80 mg/dl)
- Hepatic Dysfunction (AST > 30 U/l, ALT > 30 U/l)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01704053
|University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
|Frankfurt/Main, Hessen, Germany, 60590 |
Johann Wolfgang Goethe University Hospitals
No publications provided
||Dr. Matthias Klages, M.D., Johann Wolfgang Goethe University Hospitals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 8, 2012
||August 14, 2014
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Johann Wolfgang Goethe University Hospitals:
New Oral Anticoagulants
Thrombelastometry/-graphy (ROTEM, TEG)
Multiple Platelet Function Analyzer (Multiplate)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 20, 2014
Serine Proteinase Inhibitors
Molecular Mechanisms of Pharmacological Action