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

Bayer

Status: Completed

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01444586

XA2011-01RU (Other Identifier)

16002

Details and patient eligibility

About

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.

Enrollment: 2,293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

2,293 participants in 1 patient group

Group 1

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)