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Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01139658
First received: June 7, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions


Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy :to assess the incidence of symptomatic venous thromboembolic events in patients treated with Pradaxa after Total Hip Replacement and Total Knee Replacement surgery [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
  • Safety : Major bleeding events [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe Patients characteristics : age, gender, weight, height, cardiovascular and thromboembolic risk factors, concomitant disorders ... [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • to evaluate conditions of use of Pradaxa : dose, prescribed duration and effective duration of treatment, treatment regimen, discontinuation of treatment with Pradaxa and reason for discontinuation, compliance with treatment, concomitant therapy [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • To determine the impact of thromboprophylaxis with Pradaxa on the organisation of healthcare [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Enrollment: 1676
Study Start Date: August 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All comers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Demographic, medical and chirurgical characteristics

Criteria

Inclusion criteria:

  1. Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement
  2. Patients 18 years of age or older at the time of recruitment

Exclusion criteria:

  1. Patients presenting contraindication to prescription of Pradaxa
  2. Patients in whom long term Anti vitamin K treatment is indicated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139658

  Show 53 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01139658     History of Changes
Other Study ID Numbers: 1160.102
Study First Received: June 7, 2010
Last Updated: April 3, 2013
Health Authority: France: Haute Autorite de Sante Transparency Commission

Additional relevant MeSH terms:
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 23, 2013