At a glance
ClinicalIndex Comparison RecordN/ACompleted· 5,476 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
An observational study for Arthroplasty, Replacement and Thromboembolism. Completed, enrolled 5,476 participants across 112 sites in 9 countries.
Detailed 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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsArthroplasty, Replacement, Thromboembolism
CountriesAustria, France, Germany, Ireland, Italy, Poland, Spain, Sweden, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionJul 2011
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.4 years ago