NCT00846807

Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,476 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

Conditions

• Arthroplasty, Replacement
• Thromboembolism

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-07-01
• First posted: 2009-02-19
• Last updated: 2012-09-18
• Results posted: 2012-08-28

Locations

112 sites across 9 countries: Austria, France, Germany, Ireland, Italy, Poland, Spain, Sweden, United Kingdom