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

Bayer0 sites2,293 target enrollmentOctober 2011

ConditionsArthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee

InterventionsRivaroxaban (Xarelto, BAY59-7939)

Overview

Phase: N/A
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Bayer
Enrollment: 2293
Primary Endpoint: 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.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

July 2014

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Group 1

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Outcomes

Primary Outcomes

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.

Time Frame: Not more than 8 weeks

Secondary Outcomes

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)