NCT00986635

Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Differences in Laboratory Coagulation Parameters

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2011-04-01
• First posted: 2009-09-30
• Last updated: 2011-04-08

Locations

1 site across 1 country: Germany