Clinical trial NCT01153698: Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Venous Thromboembolism
Arthroplasty, Replacement
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: specialist care

Brief summary: 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)


Eligibility 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

Primary outcomes:
measure: Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period
timeFrame: 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)
measure: Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period
timeFrame: 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 outcomes:
measure: Percentage of Patients With MBE During Total Treatment Period
timeFrame: 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
measure: Percentage of Patients With MBE During Pre-switch Treatment Period
timeFrame: From first enoxaparin administration until last enoxaparin administration
measure: Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period
timeFrame: 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
measure: Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period
timeFrame: From first enoxaparin administration until last enoxaparin administration
measure: Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period
timeFrame: From last enoxaparin administration until first Pradaxa intake
measure: Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period
timeFrame: 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
measure: Volume of Wound Drainage (Post-operative)
timeFrame: From end of surgery (before first dosing) until 24 hours after last Pradaxa intake
measure: Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period
timeFrame: 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)
Other outcomes:
Locations:
city: Braunau
country: Austria
facility: 1160.118.43004 Boehringer Ingelheim Investigational Site
city: Ehebichl
country: Austria
facility: 1160.118.43002 Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: 1160.118.43005 Boehringer Ingelheim Investigational Site
city: Stolzalpe
country: Austria
facility: 1160.118.43016 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.118.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.118.43007 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.118.43011 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.