Arthroplasty, Replacement, Knee Clinical Trial
— SOPRANOOfficial title:
Prospective Multicentre Non-interventional Study on Compliance and Patient/Doctor Behavior of VTE Prevention in Major Orthopedic Surgery
Verified date | January 2017 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2293 |
Est. completion date | July 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer | Janssen Research & Development, LLC |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome) | Not more than 8 weeks |
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