Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00986635
First received: September 29, 2009
Last updated: April 7, 2011
Last verified: September 2009

September 29, 2009
April 7, 2011
September 2009
June 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00986635 on ClinicalTrials.gov Archive Site
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Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Retention:   Samples Without DNA
Description:

Plasma samples

Non-Probability Sample

patients after hip or knee replacement surgery

Differences in Laboratory Coagulation Parameters
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Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Ex vivo effects of low-dose rivaroxaban on specific coagulation assays and coagulation factor activities in patients under real life conditions. Thromb Haemost. 2013 Jan;109(1):127-36. doi: 10.1160/TH12-04-0228. Epub 2012 Nov 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2011
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d
  • must be able to accept blood sampling
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00986635
RIV139/09
No
Prof. Dr. Edelgard Lindhoff-Last, MD, Vascular Medicine, Johann Wolfgang Goethe University Hospital Frankfurt/Main
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Helen Mani, PhD Johann Wolfgang Goethe University Hospital Frankfurt/Main Germany
Johann Wolfgang Goethe University Hospitals
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP