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Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986635
First Posted: September 30, 2009
Last Update Posted: April 8, 2011
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:
Johann Wolfgang Goethe University Hospital
  Purpose
Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Xarelto® on different coagulation parameters.

Condition
Differences in Laboratory Coagulation Parameters

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

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

Biospecimen Retention:   Samples Without DNA
Plasma samples

Estimated Enrollment: 100
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated.

Plasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day).

Several techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.

  Eligibility

Information from the National Library of Medicine

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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
patients after hip or knee replacement surgery
Criteria

Inclusion Criteria:

  • patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d
  • must be able to accept blood sampling
  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): NCT00986635


Locations
Germany
University Hospital Frankfurt
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Helen Mani, PhD Johann Wolfgang Goethe University Hospital Frankfurt/Main Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Edelgard Lindhoff-Last, MD, Vascular Medicine, Johann Wolfgang Goethe University Hospital Frankfurt/Main
ClinicalTrials.gov Identifier: NCT00986635     History of Changes
Other Study ID Numbers: RIV139/09
First Submitted: September 29, 2009
First Posted: September 30, 2009
Last Update Posted: April 8, 2011
Last Verified: September 2009

Keywords provided by Johann Wolfgang Goethe University Hospital:
Activated partial thromboplastin time
Thrombin clotting Time
Anti-Xa-activity
Factor X-activity
Factor XIII-activity
Antithrombin (based on factor II)
Antithrombin (based on factor X<9

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