Clinical trial NCT00847301: Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
Official title: Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement
Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate renal insufficiency

Brief summary: An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment


Eligibility criteria: Inclusion criteria:

Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):

severe renal impairment (creatinine clearance \< 30 ml/min); elevated liver enzymes \> 2 upper limit of normal (ULN); 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, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment

Primary outcomes:
measure: Percentage of Patients With Major Bleeding Events (MBE)
timeFrame: 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
measure: Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
timeFrame: 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
Secondary outcomes:
measure: Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
timeFrame: 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
measure: Percentage of Patients With Major Extra-surgical Site Bleedings
timeFrame: 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
measure: Volume of Wound Drainage (Post-operative)
timeFrame: 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
Other outcomes:
Locations:
city: Wien
country: Austria
facility: 1160.84.4301 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.84.4310 Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1160.84.3311 Boehringer Ingelheim Investigational Site
city: Bordeaux
country: France
facility: 1160.84.3334 Boehringer Ingelheim Investigational Site
city: Caen Cedex 5
country: France
facility: 1160.84.3303 Boehringer Ingelheim Investigational Site
city: Clermont-Ferrand cedex 1
country: France
facility: 1160.84.3314 Boehringer Ingelheim Investigational Site
city: Creteil
country: France
facility: 1160.84.3320 Boehringer Ingelheim Investigational Site
city: DIJON Cédex
country: France
facility: 1160.84.3307 Boehringer Ingelheim Investigational Site
city: Illkirch
country: France
facility: 1160.84.3310 Boehringer Ingelheim Investigational Site
city: Le Havre
country: France
facility: 1160.84.3335 Boehringer Ingelheim Investigational Site
city: Les Lilas
country: France
facility: 1160.84.3326 Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: 1160.84.3312 Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1160.84.3305 Boehringer Ingelheim Investigational Site
city: Nantes Cédex 2
country: France
facility: 1160.84.3323 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1160.84.3302 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1160.84.3306 Boehringer Ingelheim Investigational Site
city: Pierre Bénite cedex
country: France
facility: 1160.84.3313 Boehringer Ingelheim Investigational Site
city: Poitiers Cédex
country: France
facility: 1160.84.3324 Boehringer Ingelheim Investigational Site
city: Saint Etienne Cédex 2
country: France
facility: 1160.84.3322 Boehringer Ingelheim Investigational Site
city: Saint Saulve
country: France
facility: 1160.84.3319 Boehringer Ingelheim Investigational Site
city: Toulouse Cédex 9
country: France
facility: 1160.84.3316 Boehringer Ingelheim Investigational Site
city: Vannes Cédex
country: France
facility: 1160.84.3332 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.84.04903 Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 1160.84.04947 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 1160.84.4922 Boehringer Ingelheim Investigational Site
city: Hachenburg
country: Germany
facility: 1160.84.04927 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1160.84.04929 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 1160.84.04902 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1160.84.04946 Boehringer Ingelheim Investigational Site
city: Olsberg
country: Germany
facility: 1160.84.04913 Boehringer Ingelheim Investigational Site
city: Sylt
country: Germany
facility: 1160.84.04914 Boehringer Ingelheim Investigational Site
city: Wismar
country: Germany
facility: 1160.84.04938 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1160.84.04948 Boehringer Ingelheim Investigational Site
city: Latina
country: Italy
facility: 1160.84.03908 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1160.84.03902 Boehringer Ingelheim Investigational Site
city: Monza
country: Italy
facility: 1160.84.03904 Boehringer Ingelheim Investigational Site
city: Udine
country: Italy
facility: 1160.84.03909 Boehringer Ingelheim Investigational Site
city: Badalona (Barcelona)
country: Spain
facility: 1160.84.3409 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.84.3410 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.84.3403 Boehringer Ingelheim Investigational Site
city: Malaga
country: Spain
facility: 1160.84.3405 Boehringer Ingelheim Investigational Site
city: Pamplona
country: Spain
facility: 1160.84.3404 Boehringer Ingelheim Investigational Site
city: Pozuelo de Alarcón - Madrid
country: Spain
facility: 1160.84.3412 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1160.84.3401 Boehringer Ingelheim Investigational Site
city: Zaragoza
country: Spain
facility: 1160.84.3402 Boehringer Ingelheim Investigational Site
city: Kungälv
country: Sweden
facility: 1160.84.4603 Boehringer Ingelheim Investigational Site
city: Motala
country: Sweden
facility: 1160.84.4601 Boehringer Ingelheim Investigational Site
city: Sollefteå
country: Sweden
facility: 1160.84.4604 Boehringer Ingelheim Investigational Site
city: Basildon
country: United Kingdom
facility: 1160.84.04405 Boehringer Ingelheim Investigational Site
city: Bedford
country: United Kingdom
facility: 1160.84.04408 Boehringer Ingelheim Investigational Site
city: Luton
country: United Kingdom
facility: 1160.84.04403 Boehringer Ingelheim Investigational Site
city: Wigan
country: United Kingdom
facility: 1160.84.04401 Boehringer Ingelheim Investigational Site
city: Yeovil
country: United Kingdom
facility: 1160.84.04407 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: