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

February 13, 2009
September 13, 2012
February 2009
July 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
  • 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 ] [ Designated as safety issue: No ]
    The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).
  • Efficacy: Composite of all death and documented symptomatic VTE (i.e., documented symptomatic DVT and documented symptomatic nonfatal pulmonary embolism(PE) [ Time Frame: up to 35 days ]
  • Safety: Major bleeding events(MBE) [ Time Frame: up to 35 days ]
Complete list of historical versions of study NCT00846807 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.
  • 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 ] [ Designated as safety issue: No ]
Major extra surgical site bleedings,volume of wound drainage, documented.symptomatic proximal DVT, documented symptomatic distal DVT, documented symptomatic nonfatal PE and all cause mortalitity [ Time Frame: up to 35 days ]
Not Provided
Not Provided
 
Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subgroups of the general population

  • Arthroplasty, Replacement
  • Thromboembolism
Not Provided
Patients 75 years or younger
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5476
Not Provided
July 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

Patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of > 75 years, renal impairment (creatinine clearance <50 ml/min), patients with concomitant therapy of amiodarone, 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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Ireland,   Italy,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00846807
1160.85
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP