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Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

NCT ID: NCT00846807

Last Updated: 2012-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5476 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Arthroplasty, Replacement Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients 75 years or younger

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.85.4308 Boehringer Ingelheim Investigational Site

Graz, , Austria

Site Status

1160.85.4309 Boehringer Ingelheim Investigational Site

Klagenfurt, , Austria

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1160.85.4303 Boehringer Ingelheim Investigational Site

Linz, , Austria

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1160.85.4304 Boehringer Ingelheim Investigational Site

Linz, , Austria

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1160.85.4305 Boehringer Ingelheim Investigational Site

Saint Johann/Tirol, , Austria

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1160.85.4312 Boehringer Ingelheim Investigational Site

Stolzalpe, , Austria

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1160.85.4301 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.85.4302 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.85.4310 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.85.4311 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.85.4307 Boehringer Ingelheim Investigational Site

Wels, , Austria

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1160.85.3306A Boehringer Ingelheim Investigational Site

Angers, , France

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1160.85.3318A Boehringer Ingelheim Investigational Site

Bois Guillaume Cédex, , France

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1160.85.3333A Boehringer Ingelheim Investigational Site

Bordeaux, , France

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1160.85.3310A Boehringer Ingelheim Investigational Site

Caen, , France

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1160.85.3311A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

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1160.85.3315A Boehringer Ingelheim Investigational Site

Créteil, , France

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1160.85.3305A Boehringer Ingelheim Investigational Site

Dijon Cédex, , France

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1160.85.3304A Boehringer Ingelheim Investigational Site

Illkirch-Graffenstaden, , France

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1160.85.3334A Boehringer Ingelheim Investigational Site

Le Havre, , France

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1160.85.3324A Boehringer Ingelheim Investigational Site

Les Lilas, , France

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1160.85.3309A Boehringer Ingelheim Investigational Site

Lille, , France

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1160.85.3307A Boehringer Ingelheim Investigational Site

Lyon, , France

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1160.85.3325A Boehringer Ingelheim Investigational Site

Marseille, , France

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1160.85.3323A Boehringer Ingelheim Investigational Site

Metz, , France

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1160.85.3321A Boehringer Ingelheim Investigational Site

Nantes Cédex 2, , France

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1160.85.3301A Boehringer Ingelheim Investigational Site

Paris, , France

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1160.85.3302A Boehringer Ingelheim Investigational Site

Paris, , France

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1160.85.3303A Boehringer Ingelheim Investigational Site

Paris, , France

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1160.85.3320A Boehringer Ingelheim Investigational Site

Paris, , France

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1160.85.3308A Boehringer Ingelheim Investigational Site

Pierre-Bénite, , France

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1160.85.3322A Boehringer Ingelheim Investigational Site

Poitiers Cédex, , France

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1160.85.3319A Boehringer Ingelheim Investigational Site

Saint Etienne Cédex 2, , France

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1160.85.3317A Boehringer Ingelheim Investigational Site

Saint-Saulve, , France

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1160.85.3314A Boehringer Ingelheim Investigational Site

Toulouse, , France

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1160.85.3313A Boehringer Ingelheim Investigational Site

Toulouse Cédex 9, , France

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1160.85.3331A Boehringer Ingelheim Investigational Site

Vannes Cédex, , France

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1160.85.04924 Boehringer Ingelheim Investigational Site

Bad Homburg, , Germany

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1160.85.04926 Boehringer Ingelheim Investigational Site

Bayreuth, , Germany

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1160.85.04903 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1160.85.04931 Boehringer Ingelheim Investigational Site

Bochum, , Germany

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1160.85.04930 Boehringer Ingelheim Investigational Site

Breitenbrunn, , Germany

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1160.85.04923 Boehringer Ingelheim Investigational Site

Chemnitz, , Germany

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1160.85.04947 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

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1160.85.04945 Boehringer Ingelheim Investigational Site

Fürth, , Germany

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1160.85.04912 Boehringer Ingelheim Investigational Site

Garmische-Partenkirchen, , Germany

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1160.85.04922 Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

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1160.85.04917 Boehringer Ingelheim Investigational Site

Gelsenkirchen, , Germany

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1160.85.04949 Boehringer Ingelheim Investigational Site

Günzburg, , Germany

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1160.85.04927 Boehringer Ingelheim Investigational Site

Hachenburg, , Germany

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1160.85.04910 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1160.85.04906 Boehringer Ingelheim Investigational Site

Hanover, , Germany

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1160.85.04920 Boehringer Ingelheim Investigational Site

Hof, , Germany

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1160.85.04916 Boehringer Ingelheim Investigational Site

Kamp-Linfort, , Germany

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1160.85.04939 Boehringer Ingelheim Investigational Site

Kassel, , Germany

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1160.85.04929 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

1160.85.04909 Boehringer Ingelheim Investigational Site

Landstuhl, , Germany

Site Status

1160.85.04944 Boehringer Ingelheim Investigational Site

Lubin, , Germany

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1160.85.04935 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1160.85.04902 Boehringer Ingelheim Investigational Site

Marburg, , Germany

Site Status

1160.85.04934 Boehringer Ingelheim Investigational Site

Markgröningen, , Germany

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1160.85.04918 Boehringer Ingelheim Investigational Site

Marktheidenfeld, , Germany

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1160.85.04941 Boehringer Ingelheim Investigational Site

Merseburg, , Germany

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1160.85.04952 Boehringer Ingelheim Investigational Site

Minden, , Germany

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1160.85.04943 Boehringer Ingelheim Investigational Site

München, , Germany

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1160.85.04946 Boehringer Ingelheim Investigational Site

München, , Germany

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1160.85.04904 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

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1160.85.04913 Boehringer Ingelheim Investigational Site

Olsberg, , Germany

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1160.85.04932 Boehringer Ingelheim Investigational Site

Pfortzheim, , Germany

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1160.85.04901 Boehringer Ingelheim Investigational Site

Rosenheim, , Germany

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1160.85.04915 Boehringer Ingelheim Investigational Site

Rostock, , Germany

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1160.85.04928 Boehringer Ingelheim Investigational Site

Rostock, , Germany

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1160.85.04936 Boehringer Ingelheim Investigational Site

Rotenburg/Fulda, , Germany

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1160.85.04905 Boehringer Ingelheim Investigational Site

Schwarzenbruck, , Germany

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1160.85.04914 Boehringer Ingelheim Investigational Site

Sylt, , Germany

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1160.85.04933 Boehringer Ingelheim Investigational Site

Wertheim am Main, , Germany

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1160.85.04921 Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Site Status

1160.85.04938 Boehringer Ingelheim Investigational Site

Wismar, , Germany

Site Status

1160.85.04907 Boehringer Ingelheim Investigational Site

Worms, , Germany

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1160.85.04940 Boehringer Ingelheim Investigational Site

Würzburg, , Germany

Site Status

1160.85.04948 Boehringer Ingelheim Investigational Site

Würzburg, , Germany

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1160.85.35301 Boehringer Ingelheim Investigational Site

Croom, , Ireland

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1160.85.03911 Boehringer Ingelheim Investigational Site

Bari, , Italy

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1160.85.03905 Boehringer Ingelheim Investigational Site

Florence, , Italy

Site Status

1160.85.03904 Boehringer Ingelheim Investigational Site

Genova, , Italy

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1160.85.03906 Boehringer Ingelheim Investigational Site

Jesi (an), , Italy

Site Status

1160.85.03914 Boehringer Ingelheim Investigational Site

Latina, , Italy

Site Status

1160.85.03901 Boehringer Ingelheim Investigational Site

Mantova, , Italy

Site Status

1160.85.03913 Boehringer Ingelheim Investigational Site

Ome (bs), , Italy

Site Status

1160.85.03907 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1160.85.03909 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1160.85.03910 Boehringer Ingelheim Investigational Site

Vimercate (mi), , Italy

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1160.85.4806 Boehringer Ingelheim Investigational Site

Gmina Świebodzin, , Poland

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1160.85.4805 Boehringer Ingelheim Investigational Site

Kościerzyna, , Poland

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1160.85.4804 Boehringer Ingelheim Investigational Site

Lodz, , Poland

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1160.85.4803 Boehringer Ingelheim Investigational Site

Otwock, , Poland

Site Status

1160.85.4802 Boehringer Ingelheim Investigational Site

Piekary Śląskie, , Poland

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1160.85.3404 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.85.3406 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.85.3405 Boehringer Ingelheim Investigational Site

Málaga, , Spain

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1160.85.3407 Boehringer Ingelheim Investigational Site

Pamplona, , Spain

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1160.85.3401 Boehringer Ingelheim Investigational Site

Valencia, , Spain

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1160.85.3402 Boehringer Ingelheim Investigational Site

Zaragoza, , Spain

Site Status

1160.85.4603 Boehringer Ingelheim Investigational Site

Kungälv, , Sweden

Site Status

1160.85.4601 Boehringer Ingelheim Investigational Site

Motala, , Sweden

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1160.85.4604 Boehringer Ingelheim Investigational Site

Sollefteå, , Sweden

Site Status

1160.85.04405 Boehringer Ingelheim Investigational Site

Basildon, , United Kingdom

Site Status

1160.85.04406 Boehringer Ingelheim Investigational Site

Gateshead, , United Kingdom

Site Status

1160.85.04402 Boehringer Ingelheim Investigational Site

Halifax, , United Kingdom

Site Status

1160.85.04404 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1160.85.04403 Boehringer Ingelheim Investigational Site

Luton, , United Kingdom

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1160.85.04401 Boehringer Ingelheim Investigational Site

Wigan, , United Kingdom

Site Status

Countries

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Austria France Germany Ireland Italy Poland Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27042163 (View on PubMed)

Other Identifiers

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1160.85

Identifier Type: -

Identifier Source: org_study_id