Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

Terminated

• Conditions: Thromboembolism; Arthroplasty, Replacement, Hip

• Registration Number: NCT00967447
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Open, prospective, uncontrolled, observational cohort study.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Primary Completion: 2010-01
• Results First Submitted: 2012-01-05
• Results First Submitted QC: 2012-03-05
• Results First Posted: 2012-04-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venous Thromboembolic Events	6 Months

Secondary Outcome Measures

Name	Time	Method
Major Extra Surgical Site Bleedings	From 12 To 37 Days
Volume of Wound Drainage	From 12 To 37 Days
Major Bleeding Events (MBE)	From 12 To 37 Days

Trial Locations

Locations (28)

Boehringer Ingelheim Investigational Site 11; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 15; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 12; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 18; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 19; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 10; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 13; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 16; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 4; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 21; 🇲🇽 Guadalajara, Mexico

Boehringer Ingelheim Investigational Site 5; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 8; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 22; 🇲🇽 Guadalajara, Mexico

Boehringer Ingelheim Investigational Site 25; 🇲🇽 Guadalajara, Mexico

Boehringer Ingelheim Investigational Site 28; 🇲🇽 Monterrey, Mexico

Boehringer Ingelheim Investigational Site 20; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 3; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 7; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 27; 🇲🇽 Puebla, Mexico

Boehringer Ingelheim Investigational Site 23; 🇲🇽 Guadalajara, Mexico

Boehringer Ingelheim Investigational Site 26; 🇲🇽 Puebla, Mexico

Boehringer Ingelheim Investigational Site 14; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 17; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 1; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 6; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 9; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 2; 🇲🇽 Distrito Federal, Mexico

Boehringer Ingelheim Investigational Site 24; 🇲🇽 Guadalajara, Mexico