NCT01112202

Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin 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 Pradaxa® on different coagulation parameters.

Detailed description

This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).

Conditions

• Effect of Dabigatran in Laboratory Coagulation Parameters

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2010-04-28
• Last updated: 2012-06-06

Locations

1 site across 1 country: Germany