Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

Completed

• Conditions: Effect of Dabigatran in Laboratory Coagulation Parameters

• Registration Number: NCT01112202
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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).

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2011-02
• Study Completion: 2011-04
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age > 18 y

Exclusion Criteria

• Hemorrhagic disorder
• Liver disease
• Anemia
• Severe renal impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Johann Wolfgang Goethe University Hospital; 🇩🇪 Frankfurt, Germany