Trial Condition(s):
Arthroplasty, Replacement, Hip
Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE) (SOPRANO)
Bayer Identifier:
16002
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective multicentre non-interventional study on compliance and patient/doctor behavior of VTE prevention in major orthopedic surgery
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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.Timeframe: Not more than 8 weeks
Secondary Outcome
- 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.Timeframe: Not more than 8 weeks
- Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)Timeframe: Not more than 8 weeks
Additional Information
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