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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00967447
Recruitment Status : Terminated
First Posted : August 27, 2009
Results First Posted : April 5, 2012
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
Open, prospective, uncontrolled, observational cohort study.

Condition or disease
Thromboembolism Arthroplasty, Replacement, Hip

Study Design
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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Study Start Date : February 2009
Actual Primary Completion Date : January 2010
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Venous Thromboembolic Events [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Major Bleeding Events (MBE) [ Time Frame: From 12 To 37 Days ]
  2. Major Extra Surgical Site Bleedings [ Time Frame: From 12 To 37 Days ]
  3. Volume of Wound Drainage [ Time Frame: From 12 To 37 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinics
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967447


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00967447    
Other Study ID Numbers: 1160.103
First Posted: August 27, 2009    Key Record Dates
Results First Posted: April 5, 2012
Last Update Posted: March 19, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases