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)
1160.85.4308 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
1160.85.4309 Boehringer Ingelheim Investigational Site
🇦🇹Klagenfurt, Austria
1160.85.4303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.85.4304 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.85.4305 Boehringer Ingelheim Investigational Site
🇦🇹St. Johann/Tirol, Austria
1160.85.4312 Boehringer Ingelheim Investigational Site
🇦🇹Stolzalpe, Austria
1160.85.4307 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
1160.85.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.85.4302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.85.4310 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
Scroll for more (102 remaining)1160.85.4308 Boehringer Ingelheim Investigational Site🇦🇹Graz, Austria