Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population 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 of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

Official Title
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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.

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 undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study Exclusion criteria: All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of > 75 years, renal impairment (creatinine clearance <50 ml/min), patients with concomitant therapy of amiodarone, elevated liver enzymes > 2 upper limit of normal (ULN) and/or 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 except for the above included patients groups, concomitant treatment with quinidine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients 75 years or younger<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) During Treatment Period | 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). | 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 |
| --- | --- | --- |
| 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) | 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. | 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 | 
| 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 |