Status:
TERMINATED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Thromboembolism
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18-74 years
Brief Summary
Open, prospective, uncontrolled, observational cohort study.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00967447
Start Date
February 1 2009
Last Update
February 11 2025
Active Locations (28)
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1
Boehringer Ingelheim Investigational Site 10
Distrito Federal, Mexico
2
Boehringer Ingelheim Investigational Site 11
Distrito Federal, Mexico
3
Boehringer Ingelheim Investigational Site 12
Distrito Federal, Mexico
4
Boehringer Ingelheim Investigational Site 13
Distrito Federal, Mexico