Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Arthroplasty, Replacement, Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study Exclusion criteria: All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC): severe renal impairment (creatinine clearance < 30 ml/min); elevated liver enzymes > 2 upper limit of normal (ULN); Hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal Impairment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Major Bleeding Events (MBE) | 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 | 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 Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality | Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), 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 | 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) | Volume of Wound Drainage after surgery | 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 |