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
Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.
1 other identifier
observational
2
1 country
28
Brief Summary
Open, prospective, uncontrolled, observational cohort study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedResults Posted
Study results publicly available
April 5, 2012
CompletedFebruary 11, 2025
January 1, 2025
11 months
August 13, 2009
January 5, 2012
January 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Venous Thromboembolic Events
6 Months
Secondary Outcomes (3)
Major Bleeding Events (MBE)
From 12 To 37 Days
Major Extra Surgical Site Bleedings
From 12 To 37 Days
Volume of Wound Drainage
From 12 To 37 Days
Eligibility Criteria
Primary Care Clinics
You may qualify if:
- patients age 18 years or above undergoing elective total hip or knee replacement surgery
- Written informed consent obtained for data collection and source data verification.
You may not qualify if:
- According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:
- age of \> 75 years
- renal impairment (creatinine clearance \<50ml/min)
- patients on concomitant therapy with amiodarone or verapamil.
- elevated liver enzymes \>2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival
- anaesthesia with post-operative indwelling epidural catheters
- hypersensitivity to dabigatran etexilate or to any of the excipients
- active clinically significant bleeding
- organic lesion at risk of bleeding
- spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups
- concomitant treatment with quinidine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Boehringer Ingelheim Investigational Site 10
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 11
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 12
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 13
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 14
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 15
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 16
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 17
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 18
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 19
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 1
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 20
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 2
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 3
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 4
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 5
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 6
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 7
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 8
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 9
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 21
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 22
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 23
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 24
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 25
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 28
Monterrey, Mexico
Boehringer Ingelheim Investigational Site 26
Puebla City, Mexico
Boehringer Ingelheim Investigational Site 27
Puebla City, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 27, 2009
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Last Updated
February 11, 2025
Results First Posted
April 5, 2012
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency