Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00846807
First received: February 13, 2009
Last updated: September 13, 2012
Last verified: September 2012
Results First Received: July 25, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Arthroplasty, Replacement
Thromboembolism

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 5438 patients enrolled, 5292 were treated. Treated patients are presented.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Phase IV, open-label, prospective, observational, single-arm study on surgery patients (hip and knee surgery)

Reporting Groups
  Description
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.

Participant Flow:   Overall Study
    All Patients  
STARTED     5292 [1]
COMPLETED     4660 [2]
NOT COMPLETED     632  
Adverse Event                 270  
Lost to Follow-up                 94  
Withdrawal by Subject                 56  
Non compliant with European label                 7  
Switch to other anticoagulants                 89  
No prescription after hospital discharge                 56  
Unknown                 60  
[1] Entered and treated.
[2] Completed treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  5292  
Age  
[units: Years]
Mean ± Standard Deviation
  62.6  ± 9.2  
Gender  
[units: Participants]
 
Female     3061  
Male     2231  



  Outcome Measures
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1.  Primary:   Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

2.  Primary:   Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

3.  Secondary:   Percentage of Patients With Major Extra-surgical Site Bleedings   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

4.  Secondary:   Volume of Wound Drainage (Post-operative)   [ Time Frame: From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

5.  Secondary:   Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00846807     History of Changes
Other Study ID Numbers: 1160.85
Study First Received: February 13, 2009
Results First Received: July 25, 2012
Last Updated: September 13, 2012
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