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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Matthias Klages, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01704053
First received: October 8, 2012
Last updated: August 14, 2014
Last verified: August 2014
  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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
  More Information

No publications provided

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
Study First Received: October 8, 2012
Last Updated: August 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Dabigatran
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014