Clinical trial NCT00831714: Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty
Official title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Prophylaxis of Venous Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2009-01-29
Enrollment: 19076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment has been made

Brief summary: The main goal is to provide additional information to the risk-benefit assessment of the drug.


Eligibility criteria: Inclusion Criteria:

* Female and male patients who will undergo elective hip or knee arthroplasty.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.

Primary outcomes:
measure: Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality
timeFrame: During observation period of three months
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Australia
city: Many Locations
country: Austria
city: Many Locations
country: Belgium
city: Many Locations
country: Bosnia and Herzegovina
city: Many Locations
country: Brazil
city: Many Locations
country: Canada
city: Many Locations
country: Chile
city: Many Locations
country: China
city: Many Locations
country: Colombia
city: Many Locations
country: Cyprus
city: Many Locations
country: Czech Republic
city: Many Locations
country: Denmark
city: Many Locations
country: Estonia
city: Many Locations
country: Finland
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Hong Kong
city: Many Locations
country: Hungary
city: Many Locations
country: India
city: Many Locations
country: Italy
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Latvia
city: Many Locations
country: Lebanon
city: Many Locations
country: Lithuania
city: Many Locations
country: Macedonia, The Former Yugoslav Republic of
city: Many Locations
country: Mexico
city: Many Locations
country: Netherlands
city: Many Locations
country: Norway
city: Many Locations
country: Philippines
city: Many Locations
country: Portugal
city: Many Locations
country: Serbia
city: Many Locations
country: Singapore
city: Many Locations
country: Slovakia
city: Many Locations
country: South Africa
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Switzerland
city: Many Locations
country: United Arab Emirates
city: Many Locations
country: United Kingdom
city: Many Locations
country: Venezuela
city: Many Locations
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.
citation: Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.