Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
- Conditions
- Arthroplasty, ReplacementThromboembolism
- Registration Number
- NCT00846807
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5476
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Major Extra-surgical Site Bleedings From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa Volume of Wound Drainage (Post-operative) From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.
Trial Locations
- Locations (112)
1160.85.04932 Boehringer Ingelheim Investigational Site
🇩🇪Pfortzheim, Germany
1160.85.3318A Boehringer Ingelheim Investigational Site
🇫🇷Bois Guillaume Cédex, France
1160.85.3315A Boehringer Ingelheim Investigational Site
🇫🇷Creteil, France
1160.85.3309A Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
1160.85.3304A Boehringer Ingelheim Investigational Site
🇫🇷Illkirch, France
1160.85.04924 Boehringer Ingelheim Investigational Site
🇩🇪Bad Homburg, Germany
1160.85.04945 Boehringer Ingelheim Investigational Site
🇩🇪Fürth, Germany
1160.85.04934 Boehringer Ingelheim Investigational Site
🇩🇪Markgröningen, Germany
1160.85.04918 Boehringer Ingelheim Investigational Site
🇩🇪Marktheidenfeld, Germany
1160.85.04926 Boehringer Ingelheim Investigational Site
🇩🇪Bayreuth, Germany
1160.85.04905 Boehringer Ingelheim Investigational Site
🇩🇪Schwarzenbruck, Germany
1160.85.03910 Boehringer Ingelheim Investigational Site
🇮🇹Vimercate (mi), Italy
1160.85.04931 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
1160.85.04923 Boehringer Ingelheim Investigational Site
🇩🇪Chemnitz, Germany
1160.85.04949 Boehringer Ingelheim Investigational Site
🇩🇪Günzburg, Germany
1160.85.04920 Boehringer Ingelheim Investigational Site
🇩🇪Hof, Germany
1160.85.04935 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1160.85.04909 Boehringer Ingelheim Investigational Site
🇩🇪Landstuhl, Germany
1160.85.04941 Boehringer Ingelheim Investigational Site
🇩🇪Merseburg, Germany
1160.85.04947 Boehringer Ingelheim Investigational Site
🇩🇪Erlangen, Germany
1160.85.04927 Boehringer Ingelheim Investigational Site
🇩🇪Hachenburg, Germany
1160.85.03911 Boehringer Ingelheim Investigational Site
🇮🇹Bari, Italy
1160.85.04401 Boehringer Ingelheim Investigational Site
🇬🇧Wigan, United Kingdom
1160.85.3305A Boehringer Ingelheim Investigational Site
🇫🇷DIJON Cédex, France
1160.85.3322A Boehringer Ingelheim Investigational Site
🇫🇷Poitiers Cédex, France
1160.85.3317A Boehringer Ingelheim Investigational Site
🇫🇷Saint Saulve, France
1160.85.04952 Boehringer Ingelheim Investigational Site
🇩🇪Minden, Germany
1160.85.04903 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1160.85.04916 Boehringer Ingelheim Investigational Site
🇩🇪Kamp-Linfort, Germany
1160.85.4804 Boehringer Ingelheim Investigational Site
🇵🇱Lodz, Poland
1160.85.03913 Boehringer Ingelheim Investigational Site
🇮🇹Ome (bs), Italy
1160.85.3313A Boehringer Ingelheim Investigational Site
🇫🇷Toulouse Cédex 9, France
1160.85.3331A Boehringer Ingelheim Investigational Site
🇫🇷Vannes Cédex, France
1160.85.04912 Boehringer Ingelheim Investigational Site
🇩🇪Garmische-Partenkirchen, Germany
1160.85.3405 Boehringer Ingelheim Investigational Site
🇪🇸Malaga, Spain
1160.85.04921 Boehringer Ingelheim Investigational Site
🇩🇪Wiesbaden, Germany
1160.85.04930 Boehringer Ingelheim Investigational Site
🇩🇪Breitenbrunn, Germany
1160.85.4603 Boehringer Ingelheim Investigational Site
🇸🇪Kungälv, Sweden
1160.85.04907 Boehringer Ingelheim Investigational Site
🇩🇪Worms, Germany
1160.85.03905 Boehringer Ingelheim Investigational Site
🇮🇹Firenze, Italy
1160.85.03904 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1160.85.03906 Boehringer Ingelheim Investigational Site
🇮🇹Jesi (an), Italy
1160.85.03914 Boehringer Ingelheim Investigational Site
🇮🇹Latina, Italy
1160.85.4604 Boehringer Ingelheim Investigational Site
🇸🇪Solleftea, Sweden
1160.85.04405 Boehringer Ingelheim Investigational Site
🇬🇧Basildon, United Kingdom
1160.85.04406 Boehringer Ingelheim Investigational Site
🇬🇧Gateshead, United Kingdom
1160.85.3406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.85.3402 Boehringer Ingelheim Investigational Site
🇪🇸Zaragoza, Spain
1160.85.3401 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1160.85.3407 Boehringer Ingelheim Investigational Site
🇪🇸Pamplona, Spain
1160.85.3404 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.85.4601 Boehringer Ingelheim Investigational Site
🇸🇪Motala, Sweden
1160.85.04402 Boehringer Ingelheim Investigational Site
🇬🇧Halifax, United Kingdom
1160.85.04404 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1160.85.4309 Boehringer Ingelheim Investigational Site
🇦🇹Klagenfurt, Austria
1160.85.3306A Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
1160.85.3323A Boehringer Ingelheim Investigational Site
🇫🇷Metz, France
1160.85.04928 Boehringer Ingelheim Investigational Site
🇩🇪Rostock, Germany
1160.85.04901 Boehringer Ingelheim Investigational Site
🇩🇪Rosenheim, Germany
1160.85.04948 Boehringer Ingelheim Investigational Site
🇩🇪Würzburg, Germany
1160.85.4303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.85.4305 Boehringer Ingelheim Investigational Site
🇦🇹St. Johann/Tirol, Austria
1160.85.4302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.85.4312 Boehringer Ingelheim Investigational Site
🇦🇹Stolzalpe, Austria
1160.85.4307 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
1160.85.4310 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.85.4806 Boehringer Ingelheim Investigational Site
🇵🇱Swiebodzin, Poland
1160.85.4311 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.85.35301 Boehringer Ingelheim Investigational Site
🇮🇪Croom, Ireland
1160.85.4308 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
1160.85.4304 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.85.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.85.4805 Boehringer Ingelheim Investigational Site
🇵🇱Koscierzyna, Poland
1160.85.4802 Boehringer Ingelheim Investigational Site
🇵🇱Piekary Slaskie, Poland
1160.85.4803 Boehringer Ingelheim Investigational Site
🇵🇱Otwock, Poland
1160.85.03909 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1160.85.03901 Boehringer Ingelheim Investigational Site
🇮🇹Mantova, Italy
1160.85.03907 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1160.85.04403 Boehringer Ingelheim Investigational Site
🇬🇧Luton, United Kingdom
1160.85.3333A Boehringer Ingelheim Investigational Site
🇫🇷Bordeaux, France
1160.85.3310A Boehringer Ingelheim Investigational Site
🇫🇷Caen Cedex 9, France
1160.85.3311A Boehringer Ingelheim Investigational Site
🇫🇷Clermont-Ferrand cedex 1, France
1160.85.3334A Boehringer Ingelheim Investigational Site
🇫🇷Le Havre, France
1160.85.3307A Boehringer Ingelheim Investigational Site
🇫🇷Lyon, France
1160.85.3324A Boehringer Ingelheim Investigational Site
🇫🇷Les Lilas, France
1160.85.3325A Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1160.85.3321A Boehringer Ingelheim Investigational Site
🇫🇷Nantes Cédex 2, France
1160.85.3301A Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 10, France
1160.85.3302A Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 14, France
1160.85.3308A Boehringer Ingelheim Investigational Site
🇫🇷Pierre Bénite cedex, France
1160.85.3319A Boehringer Ingelheim Investigational Site
🇫🇷Saint Etienne Cédex 2, France
1160.85.3314A Boehringer Ingelheim Investigational Site
🇫🇷Toulouse Cedex 9, France
1160.85.04902 Boehringer Ingelheim Investigational Site
🇩🇪Marburg, Germany
1160.85.04929 Boehringer Ingelheim Investigational Site
🇩🇪Koblenz, Germany
1160.85.04922 Boehringer Ingelheim Investigational Site
🇩🇪Gelnhausen, Germany
1160.85.04917 Boehringer Ingelheim Investigational Site
🇩🇪Gelsenkirchen, Germany
1160.85.04906 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1160.85.04939 Boehringer Ingelheim Investigational Site
🇩🇪Kassel, Germany
1160.85.04944 Boehringer Ingelheim Investigational Site
🇩🇪Lübben, Germany
1160.85.04943 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1160.85.04946 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1160.85.04904 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1160.85.04936 Boehringer Ingelheim Investigational Site
🇩🇪Rotenburg/Fulda, Germany
1160.85.04914 Boehringer Ingelheim Investigational Site
🇩🇪Sylt, Germany
1160.85.04913 Boehringer Ingelheim Investigational Site
🇩🇪Olsberg, Germany
1160.85.04915 Boehringer Ingelheim Investigational Site
🇩🇪Rostock, Germany
1160.85.04933 Boehringer Ingelheim Investigational Site
🇩🇪Wertheim, Germany
1160.85.04938 Boehringer Ingelheim Investigational Site
🇩🇪Wismar, Germany
1160.85.04940 Boehringer Ingelheim Investigational Site
🇩🇪Würzburg, Germany
1160.85.3303A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1160.85.3320A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1160.85.04910 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany