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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-01

Brief Summary

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Open, prospective, uncontrolled, observational cohort study.

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Detailed Description

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Conditions

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Thromboembolism Arthroplasty, Replacement, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No