Clinical trial NCT00846807: Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
Official title: Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement
Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 5476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subgroups of the general population

Brief summary: An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE


Eligibility criteria: Inclusion criteria:

Patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of \> 75 years, renal impairment (creatinine clearance \<50 ml/min), patients with concomitant therapy of amiodarone, 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: Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period
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: 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 end of surgery (before first dosing) 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 Single Components of Composite of 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
Other outcomes:
Locations:
city: Graz
country: Austria
facility: 1160.85.4308 Boehringer Ingelheim Investigational Site
city: Klagenfurt
country: Austria
facility: 1160.85.4309 Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: 1160.85.4303 Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: 1160.85.4304 Boehringer Ingelheim Investigational Site
city: St. Johann/Tirol
country: Austria
facility: 1160.85.4305 Boehringer Ingelheim Investigational Site
city: Stolzalpe
country: Austria
facility: 1160.85.4312 Boehringer Ingelheim Investigational Site
city: Wels
country: Austria
facility: 1160.85.4307 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.85.4301 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.85.4302 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.85.4310 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.85.4311 Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1160.85.3306A Boehringer Ingelheim Investigational Site
city: Bois Guillaume Cédex
country: France
facility: 1160.85.3318A Boehringer Ingelheim Investigational Site
city: Bordeaux
country: France
facility: 1160.85.3333A Boehringer Ingelheim Investigational Site
city: Caen Cedex 9
country: France
facility: 1160.85.3310A Boehringer Ingelheim Investigational Site
city: Clermont-Ferrand cedex 1
country: France
facility: 1160.85.3311A Boehringer Ingelheim Investigational Site
city: Creteil
country: France
facility: 1160.85.3315A Boehringer Ingelheim Investigational Site
city: DIJON Cédex
country: France
facility: 1160.85.3305A Boehringer Ingelheim Investigational Site
city: Illkirch
country: France
facility: 1160.85.3304A Boehringer Ingelheim Investigational Site
city: Le Havre
country: France
facility: 1160.85.3334A Boehringer Ingelheim Investigational Site
city: Les Lilas
country: France
facility: 1160.85.3324A Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 1160.85.3309A Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: 1160.85.3307A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1160.85.3325A Boehringer Ingelheim Investigational Site
city: Metz
country: France
facility: 1160.85.3323A Boehringer Ingelheim Investigational Site
city: Nantes Cédex 2
country: France
facility: 1160.85.3321A Boehringer Ingelheim Investigational Site
city: Paris cedex 10
country: France
facility: 1160.85.3301A Boehringer Ingelheim Investigational Site
city: Paris cedex 14
country: France
facility: 1160.85.3302A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1160.85.3303A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1160.85.3320A Boehringer Ingelheim Investigational Site
city: Pierre Bénite cedex
country: France
facility: 1160.85.3308A Boehringer Ingelheim Investigational Site
city: Poitiers Cédex
country: France
facility: 1160.85.3322A Boehringer Ingelheim Investigational Site
city: Saint Etienne Cédex 2
country: France
facility: 1160.85.3319A Boehringer Ingelheim Investigational Site
city: Saint Saulve
country: France
facility: 1160.85.3317A Boehringer Ingelheim Investigational Site
city: Toulouse Cedex 9
country: France
facility: 1160.85.3314A Boehringer Ingelheim Investigational Site
city: Toulouse Cédex 9
country: France
facility: 1160.85.3313A Boehringer Ingelheim Investigational Site
city: Vannes Cédex
country: France
facility: 1160.85.3331A Boehringer Ingelheim Investigational Site
city: Bad Homburg
country: Germany
facility: 1160.85.04924 Boehringer Ingelheim Investigational Site
city: Bayreuth
country: Germany
facility: 1160.85.04926 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.85.04903 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 1160.85.04931 Boehringer Ingelheim Investigational Site
city: Breitenbrunn
country: Germany
facility: 1160.85.04930 Boehringer Ingelheim Investigational Site
city: Chemnitz
country: Germany
facility: 1160.85.04923 Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 1160.85.04947 Boehringer Ingelheim Investigational Site
city: Fürth
country: Germany
facility: 1160.85.04945 Boehringer Ingelheim Investigational Site
city: Garmische-Partenkirchen
country: Germany
facility: 1160.85.04912 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 1160.85.04922 Boehringer Ingelheim Investigational Site
city: Gelsenkirchen
country: Germany
facility: 1160.85.04917 Boehringer Ingelheim Investigational Site
city: Günzburg
country: Germany
facility: 1160.85.04949 Boehringer Ingelheim Investigational Site
city: Hachenburg
country: Germany
facility: 1160.85.04927 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1160.85.04910 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1160.85.04906 Boehringer Ingelheim Investigational Site
city: Hof
country: Germany
facility: 1160.85.04920 Boehringer Ingelheim Investigational Site
city: Kamp-Linfort
country: Germany
facility: 1160.85.04916 Boehringer Ingelheim Investigational Site
city: Kassel
country: Germany
facility: 1160.85.04939 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1160.85.04929 Boehringer Ingelheim Investigational Site
city: Landstuhl
country: Germany
facility: 1160.85.04909 Boehringer Ingelheim Investigational Site
city: Lübben
country: Germany
facility: 1160.85.04944 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1160.85.04935 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 1160.85.04902 Boehringer Ingelheim Investigational Site
city: Markgröningen
country: Germany
facility: 1160.85.04934 Boehringer Ingelheim Investigational Site
city: Marktheidenfeld
country: Germany
facility: 1160.85.04918 Boehringer Ingelheim Investigational Site
city: Merseburg
country: Germany
facility: 1160.85.04941 Boehringer Ingelheim Investigational Site
city: Minden
country: Germany
facility: 1160.85.04952 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1160.85.04943 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1160.85.04946 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1160.85.04904 Boehringer Ingelheim Investigational Site
city: Olsberg
country: Germany
facility: 1160.85.04913 Boehringer Ingelheim Investigational Site
city: Pfortzheim
country: Germany
facility: 1160.85.04932 Boehringer Ingelheim Investigational Site
city: Rosenheim
country: Germany
facility: 1160.85.04901 Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: 1160.85.04915 Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: 1160.85.04928 Boehringer Ingelheim Investigational Site
city: Rotenburg/Fulda
country: Germany
facility: 1160.85.04936 Boehringer Ingelheim Investigational Site
city: Schwarzenbruck
country: Germany
facility: 1160.85.04905 Boehringer Ingelheim Investigational Site
city: Sylt
country: Germany
facility: 1160.85.04914 Boehringer Ingelheim Investigational Site
city: Wertheim
country: Germany
facility: 1160.85.04933 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1160.85.04921 Boehringer Ingelheim Investigational Site
city: Wismar
country: Germany
facility: 1160.85.04938 Boehringer Ingelheim Investigational Site
city: Worms
country: Germany
facility: 1160.85.04907 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1160.85.04940 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1160.85.04948 Boehringer Ingelheim Investigational Site
city: Croom
country: Ireland
facility: 1160.85.35301 Boehringer Ingelheim Investigational Site
city: Bari
country: Italy
facility: 1160.85.03911 Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: 1160.85.03905 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1160.85.03904 Boehringer Ingelheim Investigational Site
city: Jesi (an)
country: Italy
facility: 1160.85.03906 Boehringer Ingelheim Investigational Site
city: Latina
country: Italy
facility: 1160.85.03914 Boehringer Ingelheim Investigational Site
city: Mantova
country: Italy
facility: 1160.85.03901 Boehringer Ingelheim Investigational Site
city: Ome (bs)
country: Italy
facility: 1160.85.03913 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1160.85.03907 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1160.85.03909 Boehringer Ingelheim Investigational Site
city: Vimercate (mi)
country: Italy
facility: 1160.85.03910 Boehringer Ingelheim Investigational Site
city: Koscierzyna
country: Poland
facility: 1160.85.4805 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1160.85.4804 Boehringer Ingelheim Investigational Site
city: Otwock
country: Poland
facility: 1160.85.4803 Boehringer Ingelheim Investigational Site
city: Piekary Slaskie
country: Poland
facility: 1160.85.4802 Boehringer Ingelheim Investigational Site
city: Swiebodzin
country: Poland
facility: 1160.85.4806 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.85.3404 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.85.3406 Boehringer Ingelheim Investigational Site
city: Malaga
country: Spain
facility: 1160.85.3405 Boehringer Ingelheim Investigational Site
city: Pamplona
country: Spain
facility: 1160.85.3407 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1160.85.3401 Boehringer Ingelheim Investigational Site
city: Zaragoza
country: Spain
facility: 1160.85.3402 Boehringer Ingelheim Investigational Site
city: Kungälv
country: Sweden
facility: 1160.85.4603 Boehringer Ingelheim Investigational Site
city: Motala
country: Sweden
facility: 1160.85.4601 Boehringer Ingelheim Investigational Site
city: Solleftea
country: Sweden
facility: 1160.85.4604 Boehringer Ingelheim Investigational Site
city: Basildon
country: United Kingdom
facility: 1160.85.04405 Boehringer Ingelheim Investigational Site
city: Gateshead
country: United Kingdom
facility: 1160.85.04406 Boehringer Ingelheim Investigational Site
city: Halifax
country: United Kingdom
facility: 1160.85.04402 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.85.04404 Boehringer Ingelheim Investigational Site
city: Luton
country: United Kingdom
facility: 1160.85.04403 Boehringer Ingelheim Investigational Site
city: Wigan
country: United Kingdom
facility: 1160.85.04401 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4. eCollection 2016.