Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Study Overview
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Brief Summary
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Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions

Official Title
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Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement Patients 18 years of age or older at the time of recruitment Exclusion criteria: Patients presenting contraindication to prescription of Pradaxa Patients in whom long term Anti vitamin K treatment is indicated

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 |
| --- | --- |
| All comers<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Symptomatic Venous Thromboembolic Events | Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE). | 11 weeks | 
| Occurrence of Major Bleeding Events | Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE). | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of Pradaxa at Initiation |  | Baseline | 
| Duration Between Surgery and First Dose of Pradaxa |  | 11 weeks | 
| Duration of Treatment |  | 11 weeks | 
| Proportion of Patients With a Preoperative ALT Measurement |  | 11 weeks | 
| Adherence to Treatment | The adherence to treatment was measured by patient declaration. | 11 weeks | 
| Concomitant Treatments | Concomitant treatments prescribed at hospital discharge. | 11 weeks | 
| Number of Patients Who Switched to Another Anticoagulant Therapy | Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose. | 11 weeks | 
| Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge |  | 11 weeks | 
| Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge |  | 11 weeks | 
| Reasons for Nurse Visits on the Day of Hospital Discharge |  | 11 weeks | 
| Frequency of Nurse Visits on the Day of Hospital Discharge |  | 11 weeks | 
| Duration of Unplanned Hospitalizations at Visit 3 |  | 11 weeks | 
| Reasons for Unplanned Hospitalizations at Visit 3 |  | 11 weeks | 
| Reasons for Usual Follow-up |  | 11 weeks |