Clinical trial NCT00967447: Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
Official title: Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thromboembolism
Arthroplasty, Replacement, Hip
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinics

Brief summary: Open, prospective, uncontrolled, observational cohort study.


Eligibility criteria: Inclusion criteria:

* patients age 18 years or above undergoing elective total hip or knee replacement surgery
* Written informed consent obtained for data collection and source data verification.

Exclusion criteria:

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:

* age of \> 75 years
* renal impairment (creatinine clearance \<50ml/min)
* patients on concomitant therapy with amiodarone or verapamil.
* 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

Primary outcomes:
measure: Venous Thromboembolic Events
timeFrame: 6 Months
Secondary outcomes:
measure: Major Bleeding Events (MBE)
timeFrame: From 12 To 37 Days
measure: Major Extra Surgical Site Bleedings
timeFrame: From 12 To 37 Days
measure: Volume of Wound Drainage
timeFrame: From 12 To 37 Days
Other outcomes:
Locations:
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 10
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 11
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 12
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 13
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 14
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 15
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 16
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 17
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 18
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 19
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 1
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 20
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 2
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 3
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 4
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 5
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 6
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 7
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 8
city: Distrito Federal
country: Mexico
facility: Boehringer Ingelheim Investigational Site 9
city: Guadalajara
country: Mexico
facility: Boehringer Ingelheim Investigational Site 21
city: Guadalajara
country: Mexico
facility: Boehringer Ingelheim Investigational Site 22
city: Guadalajara
country: Mexico
facility: Boehringer Ingelheim Investigational Site 23
city: Guadalajara
country: Mexico
facility: Boehringer Ingelheim Investigational Site 24
city: Guadalajara
country: Mexico
facility: Boehringer Ingelheim Investigational Site 25
city: Monterrey
country: Mexico
facility: Boehringer Ingelheim Investigational Site 28
city: Puebla
country: Mexico
facility: Boehringer Ingelheim Investigational Site 26
city: Puebla
country: Mexico
facility: Boehringer Ingelheim Investigational Site 27
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: