check_circleStudy Completed
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Bayer Identifier:
16002
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
2293Trial Dates
October 2011 - July 2014Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Russia |
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.date_rangeTime Frame:Not more than 8 weeksenhanced_encryptionNoSafety Issue:
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.date_rangeTime Frame:Not more than 8 weeksenhanced_encryptionNoSafety Issue:
- Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)date_rangeTime Frame:Not more than 8 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A