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

This study is currently recruiting participants.

Verified October 2012 by Johann Wolfgang Goethe University Hospitals

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: October 10, 2012

Last verified: October 2012

History of Changes

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:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Dabigatran Dabigatran etexilate Rivaroxaban Dabigatran etexilate mesylate

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Estimated Enrollment:	34
Study Start Date:	October 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704053

Contacts

Contact: Matthias Klages, M.D.

0049 6963015998

matthias.klages@kgu.de

Locations

Germany
University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy	Recruiting
Frankfurt/Main, Hessen, Germany, 60590
Contact: Matthias Klages, M.D. 0049 6963015998 matthias.klages@kgu.de
Principal Investigator: Matthias Klages, M.D.

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:	October 10, 2012
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:

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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