Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

Completed

• Conditions: Differences in Laboratory Coagulation Parameters

• Registration Number: NCT00986635
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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.

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2010-06
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt am Main, Germany