Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01153698
First received: June 29, 2010
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR)


Condition Intervention
Venous Thromboembolism
Arthroplasty, Replacement
Drug: dabigatran

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Cohort Study to Evaluate the Safety and Efficacy of Switching From Lovenox (Enoxaparin) 40mg to Pradaxa (Dabigatran Etexilate) 220mg in Patients Undergoing Elective Total Hip or Knee Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period [ Time Frame: From last enoxaparin intake until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ Designated as safety issue: Yes ]
    Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs 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 Events During the Switch-/ Post-switch Treatment Period [ Time Frame: From last enoxaparin intake until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ 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).


Secondary Outcome Measures:
  • Percentage of Patients With MBE During Total Treatment Period [ Time Frame: From first enoxaparin intake until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ Designated as safety issue: Yes ]
    MBEs were defined according to the modified McMaster criteria. The criteria for MBEs 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. Total treatment period is defined from first enoxaparin intake to 24h after last Pradaxa intake or to 35h after last enoxaparin intake if no switch was performed.

  • Percentage of Patients With MBE During Pre-switch Treatment Period [ Time Frame: From first enoxaparin intake until last enoxaparin intake (administration according to package labelling) ] [ Designated as safety issue: Yes ]
    MBEs were defined according to the modified McMaster criteria. The criteria for MBEs 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 sVTE and All-cause Mortality Events During Total Treatment Period [ Time Frame: From first enoxaparin intake until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ Designated as safety issue: No ]
    sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. Total treatment period is defined from first enoxaparin intake to 24h after last Pradaxa intake or to 35h after last enoxaparin intake if no switch was performed.

  • Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period [ Time Frame: From first enoxaparin intake until last enoxaparin intake (administration according to package labelling) ] [ Designated as safety issue: No ]
    sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.

  • Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period [ Time Frame: From last enoxaparin intake until first Pradaxa intake (administration according to package labelling) ] [ Designated as safety issue: No ]
    sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. Switch treatment period is the interval from last enoxaparin intake to first Pradaxa intake.

  • Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period [ Time Frame: From first enoxaparin intake until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ 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 Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ 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 Events During Total Treatment Period [ Time Frame: From first enoxaparin intake until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) ] [ Designated as safety issue: No ]
    Total treatment period is defined from first enoxaparin intake to 24h after last Pradaxa intake or to 35h after last enoxaparin intake if no switch was performed.


Enrollment: 167
Study Start Date: August 2010
Groups/Cohorts Assigned Interventions
patients after hip or knee replacement Drug: dabigatran
anticoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

specialist care

Criteria

Inclusion criteria:

patients age 18 years or above undergoing elective total hip or knee replacement surgery

Exclusion criteria:

according to the label recommendation for Pradaxa 220 mg QD

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153698

Locations
Austria
1160.118.43004 Boehringer Ingelheim Investigational Site
Braunau, Austria
1160.118.43002 Boehringer Ingelheim Investigational Site
Ehebichl, Austria
1160.118.43005 Boehringer Ingelheim Investigational Site
Graz, Austria
1160.118.43016 Boehringer Ingelheim Investigational Site
Stolzalpe, Austria
1160.118.43001 Boehringer Ingelheim Investigational Site
Wien, Austria
1160.118.43011 Boehringer Ingelheim Investigational Site
Wien, Austria
1160.118.43007 Boehringer Ingelheim Investigational Site
Wien, Austria
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01153698     History of Changes
Other Study ID Numbers: 1160.118
Study First Received: June 29, 2010
Results First Received: November 30, 2012
Last Updated: November 30, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on April 17, 2014