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

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

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)

Study Overview

• Status: Terminated
• Conditions: Venous Thromboembolism; Arthroplasty, Replacement
• Intervention / Treatment: Drug: dabigatran

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• Austria
  • Braunau, Austria
    • 1160.118.43004 Boehringer Ingelheim Investigational Site
  • Ehebichl, Austria
    • 1160.118.43002 Boehringer Ingelheim Investigational Site
  • Graz, Austria
    • 1160.118.43005 Boehringer Ingelheim Investigational Site
  • Stolzalpe, Austria
    • 1160.118.43016 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1160.118.43001 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1160.118.43007 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1160.118.43011 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

specialist care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients after hip or knee replacement	Drug: dabigatran; anticoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period	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.	From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period	sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).	From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With MBE During Total Treatment Period	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.	From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Percentage of Patients With MBE During Pre-switch Treatment Period	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.	From first enoxaparin administration until last enoxaparin administration
Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period	sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.	From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period	sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.	From first enoxaparin administration until last enoxaparin administration
Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period	sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism	From last enoxaparin administration until first Pradaxa intake
Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period	Major extra-surgical site bleedings include all major bleedings not occurred at surgical site	From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Volume of Wound Drainage (Post-operative)	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.	From end of surgery (before first dosing) until 24 hours after last Pradaxa intake
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period	Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.	From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

General Publications

• Wurnig C, Clemens A, Rauscher H, Kleine E, Feuring M, Windhager R, Grohs J. Safety and efficacy of switching from low molecular weight heparin to dabigatran in patients undergoing elective total hip or knee replacement surgery. Thromb J. 2015 Nov 26;13:37. doi: 10.1186/s12959-015-0066-9. eCollection 2015.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 21, 2011
• Study Completion (Actual): December 21, 2011

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimated): June 30, 2010

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran
• Other Study ID Numbers: 1160.118