Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)

Study Overview
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Brief Summary
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This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in real life thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.

Official Title
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Prospective Multicentre Non-interventional Study on Compliance and Patient/Doctor Behavior of VTE Prevention in Major Orthopedic Surgery

Conditions
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Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients ≥ 18 years old Elective hip or knee replacement Planned VTE prevention with Xarelto Written informed consent The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study. Exclusion Criteria: Contraindications for the use of Xarelto in accordance with the effective instruction Any reasons of medical and non-medical character, which in the opinion of the physician can hamper participation of the patient in NIS, including a potentially low compliance, impossibility of making the final visit due to distant place of residence of the patient.

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 |
| --- | --- |
| Group 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Xarelto is indicated are fit for participation in this non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real life out-patient thromboprophylaxis after arthroplasty: Share of patients who follow physician's prescriptions; true duration of out-patient thromboprophylaxis; duration of treatment interruptions; in case of switching - reasons, drug regimen. |  | Not more than 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive characteristics of prescription behaviour of orthopedists (VTE prevention recommended at discharge): continuation of rivaroxaban, switching to other products (name, dose, duration, efficacy control), mechanical prophylaxis, etc. |  | Not more than 8 weeks | 
| Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome) |  | Not more than 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-interventional, Xarelto, knee replacement, hip replecement, Russia