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

NCT00846807 | Completed Results

• 1 other identifier: 1160.85
• Study Type: observational
• Target: 5,476
• Locations: 9 countries
• Sites: 112

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

Conditions

Arthroplasty, Replacement; Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period

  Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation

  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

• Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality

  The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).

  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 (3)

• Percentage of Patients With Major Extra-surgical Site Bleedings

  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

• Volume of Wound Drainage (Post-operative)

  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

• Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality

  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

Study Arms (1)

Patients 75 years or younger

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subgroups of the general population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (112)

1160.85.4308 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1160.85.4309 Boehringer Ingelheim Investigational Site

Klagenfurt, Austria

Location

1160.85.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1160.85.4304 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1160.85.4305 Boehringer Ingelheim Investigational Site

Saint Johann/Tirol, Austria

Location

1160.85.4312 Boehringer Ingelheim Investigational Site

Stolzalpe, Austria

Location

1160.85.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.85.4302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.85.4310 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.85.4311 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.85.4307 Boehringer Ingelheim Investigational Site

Wels, Austria

Location

1160.85.3306A Boehringer Ingelheim Investigational Site

Angers, France

Location

1160.85.3318A Boehringer Ingelheim Investigational Site

Bois Guillaume Cédex, France

Location

1160.85.3333A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

1160.85.3310A Boehringer Ingelheim Investigational Site

Caen, France

Location

1160.85.3311A Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

1160.85.3315A Boehringer Ingelheim Investigational Site

Créteil, France

Location

1160.85.3305A Boehringer Ingelheim Investigational Site

Dijon Cédex, France

Location

1160.85.3304A Boehringer Ingelheim Investigational Site

Illkirch-Graffenstaden, France

Location

1160.85.3334A Boehringer Ingelheim Investigational Site

Le Havre, France

Location

1160.85.3324A Boehringer Ingelheim Investigational Site

Les Lilas, France

Location

1160.85.3309A Boehringer Ingelheim Investigational Site

Lille, France

Location

1160.85.3307A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1160.85.3325A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1160.85.3323A Boehringer Ingelheim Investigational Site

Metz, France

Location

1160.85.3321A Boehringer Ingelheim Investigational Site

Nantes Cédex 2, France

Location

1160.85.3301A Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.85.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.85.3303A Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.85.3320A Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.85.3308A Boehringer Ingelheim Investigational Site

Pierre-Bénite, France

Location

1160.85.3322A Boehringer Ingelheim Investigational Site

Poitiers Cédex, France

Location

1160.85.3319A Boehringer Ingelheim Investigational Site

Saint Etienne Cédex 2, France

Location

1160.85.3317A Boehringer Ingelheim Investigational Site

Saint-Saulve, France

Location

1160.85.3314A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1160.85.3313A Boehringer Ingelheim Investigational Site

Toulouse Cédex 9, France

Location

1160.85.3331A Boehringer Ingelheim Investigational Site

Vannes Cédex, France

Location

1160.85.04924 Boehringer Ingelheim Investigational Site

Bad Homburg, Germany

Location

1160.85.04926 Boehringer Ingelheim Investigational Site

Bayreuth, Germany

Location

1160.85.04903 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.85.04931 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

1160.85.04930 Boehringer Ingelheim Investigational Site

Breitenbrunn, Germany

Location

1160.85.04923 Boehringer Ingelheim Investigational Site

Chemnitz, Germany

Location

1160.85.04947 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1160.85.04945 Boehringer Ingelheim Investigational Site

Fürth, Germany

Location

1160.85.04912 Boehringer Ingelheim Investigational Site

Garmische-Partenkirchen, Germany

Location

1160.85.04922 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

1160.85.04917 Boehringer Ingelheim Investigational Site

Gelsenkirchen, Germany

Location

1160.85.04949 Boehringer Ingelheim Investigational Site

Günzburg, Germany

Location

1160.85.04927 Boehringer Ingelheim Investigational Site

Hachenburg, Germany

Location

1160.85.04910 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1160.85.04906 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1160.85.04920 Boehringer Ingelheim Investigational Site

Hof, Germany

Location

1160.85.04916 Boehringer Ingelheim Investigational Site

Kamp-Linfort, Germany

Location

1160.85.04939 Boehringer Ingelheim Investigational Site

Kassel, Germany

Location

1160.85.04929 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

1160.85.04909 Boehringer Ingelheim Investigational Site

Landstuhl, Germany

Location

1160.85.04944 Boehringer Ingelheim Investigational Site

Lubin, Germany

Location

1160.85.04935 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1160.85.04902 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

1160.85.04934 Boehringer Ingelheim Investigational Site

Markgröningen, Germany

Location

1160.85.04918 Boehringer Ingelheim Investigational Site

Marktheidenfeld, Germany

Location

1160.85.04941 Boehringer Ingelheim Investigational Site

Merseburg, Germany

Location

1160.85.04952 Boehringer Ingelheim Investigational Site

Minden, Germany

Location

1160.85.04943 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.85.04946 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.85.04904 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1160.85.04913 Boehringer Ingelheim Investigational Site

Olsberg, Germany

Location

1160.85.04932 Boehringer Ingelheim Investigational Site

Pfortzheim, Germany

Location

1160.85.04901 Boehringer Ingelheim Investigational Site

Rosenheim, Germany

Location

1160.85.04915 Boehringer Ingelheim Investigational Site

Rostock, Germany

Location

1160.85.04928 Boehringer Ingelheim Investigational Site

Rostock, Germany

Location

1160.85.04936 Boehringer Ingelheim Investigational Site

Rotenburg/Fulda, Germany

Location

1160.85.04905 Boehringer Ingelheim Investigational Site

Schwarzenbruck, Germany

Location

1160.85.04914 Boehringer Ingelheim Investigational Site

Sylt, Germany

Location

1160.85.04933 Boehringer Ingelheim Investigational Site

Wertheim am Main, Germany

Location

1160.85.04921 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

1160.85.04938 Boehringer Ingelheim Investigational Site

Wismar, Germany

Location

1160.85.04907 Boehringer Ingelheim Investigational Site

Worms, Germany

Location

1160.85.04940 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1160.85.04948 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1160.85.35301 Boehringer Ingelheim Investigational Site

Croom, Ireland

Location

1160.85.03911 Boehringer Ingelheim Investigational Site

Bari, Italy

Location

1160.85.03905 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

1160.85.03904 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1160.85.03906 Boehringer Ingelheim Investigational Site

Jesi (an), Italy

Location

1160.85.03914 Boehringer Ingelheim Investigational Site

Latina, Italy

Location

1160.85.03901 Boehringer Ingelheim Investigational Site

Mantova, Italy

Location

1160.85.03913 Boehringer Ingelheim Investigational Site

Ome (bs), Italy

Location

1160.85.03907 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1160.85.03909 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1160.85.03910 Boehringer Ingelheim Investigational Site

Vimercate (mi), Italy

Location

1160.85.4806 Boehringer Ingelheim Investigational Site

Gmina Świebodzin, Poland

Location

1160.85.4805 Boehringer Ingelheim Investigational Site

Kościerzyna, Poland

Location

1160.85.4804 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1160.85.4803 Boehringer Ingelheim Investigational Site

Otwock, Poland

Location

1160.85.4802 Boehringer Ingelheim Investigational Site

Piekary Śląskie, Poland

Location

1160.85.3404 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.85.3406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.85.3405 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1160.85.3407 Boehringer Ingelheim Investigational Site

Pamplona, Spain

Location

1160.85.3401 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.85.3402 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

1160.85.4603 Boehringer Ingelheim Investigational Site

Kungälv, Sweden

Location

1160.85.4601 Boehringer Ingelheim Investigational Site

Motala, Sweden

Location

1160.85.4604 Boehringer Ingelheim Investigational Site

Sollefteå, Sweden

Location

1160.85.04405 Boehringer Ingelheim Investigational Site

Basildon, United Kingdom

Location

1160.85.04406 Boehringer Ingelheim Investigational Site

Gateshead, United Kingdom

Location

1160.85.04402 Boehringer Ingelheim Investigational Site

Halifax, United Kingdom

Location

1160.85.04404 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.85.04403 Boehringer Ingelheim Investigational Site

Luton, United Kingdom

Location

1160.85.04401 Boehringer Ingelheim Investigational Site

Wigan, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27042163 DERIVED

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 19, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Last Updated: September 18, 2012
• Results First Posted: August 28, 2012

Record last verified: 2012-09

Locations

PL (5); DE (44); FR (26); GB (6); AU (11); SE (3); IT (10); ES (6); IE (1)