Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthroplasty, Replacement
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 472
- Locations
- 53
- Primary Endpoint
- Percentage of Patients With Major Bleeding Events (MBE)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Patients With Major Bleeding Events (MBE)
Time Frame: 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
Time Frame: 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) and All Cause Mortality.
Secondary Outcomes
- Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism 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)
- 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)
- Volume of Wound Drainage (Post-operative)(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)