Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00846807
First received: February 13, 2009
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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


Condition
Arthroplasty, Replacement
Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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

  • Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Patients With Major Extra-surgical Site Bleedings [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Volume of Wound Drainage (Post-operative) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.

  • Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 5476
Study Start Date: February 2009
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients 75 years or younger

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subgroups of the general population

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846807

  Hide Study Locations
Locations
Austria
1160.85.4308 Boehringer Ingelheim Investigational Site
Graz, Austria
1160.85.4309 Boehringer Ingelheim Investigational Site
Klagenfurt, Austria
1160.85.4303 Boehringer Ingelheim Investigational Site
Linz, Austria
1160.85.4304 Boehringer Ingelheim Investigational Site
Linz, Austria
1160.85.4305 Boehringer Ingelheim Investigational Site
St. Johann/Tirol, Austria
1160.85.4312 Boehringer Ingelheim Investigational Site
Stolzalpe, Austria
1160.85.4307 Boehringer Ingelheim Investigational Site
Wels, Austria
1160.85.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
1160.85.4302 Boehringer Ingelheim Investigational Site
Wien, Austria
1160.85.4310 Boehringer Ingelheim Investigational Site
Wien, Austria
1160.85.4311 Boehringer Ingelheim Investigational Site
Wien, Austria
France
1160.85.3306A Boehringer Ingelheim Investigational Site
Angers, France
1160.85.3318A Boehringer Ingelheim Investigational Site
Bois Guillaume Cédex, France
1160.85.3333A Boehringer Ingelheim Investigational Site
Bordeaux, France
1160.85.3310A Boehringer Ingelheim Investigational Site
Caen Cedex 9, France
1160.85.3311A Boehringer Ingelheim Investigational Site
Clermont-Ferrand cedex 1, France
1160.85.3315A Boehringer Ingelheim Investigational Site
Creteil, France
1160.85.3305A Boehringer Ingelheim Investigational Site
DIJON Cédex, France
1160.85.3304A Boehringer Ingelheim Investigational Site
Illkirch, France
1160.85.3334A Boehringer Ingelheim Investigational Site
Le Havre, France
1160.85.3324A Boehringer Ingelheim Investigational Site
Les Lilas, France
1160.85.3309A Boehringer Ingelheim Investigational Site
Lille cedex, France
1160.85.3307A Boehringer Ingelheim Investigational Site
Lyon, France
1160.85.3325A Boehringer Ingelheim Investigational Site
Marseille, France
1160.85.3323A Boehringer Ingelheim Investigational Site
Metz, France
1160.85.3321A Boehringer Ingelheim Investigational Site
Nantes Cédex 2, France
1160.85.3303A Boehringer Ingelheim Investigational Site
Paris, France
1160.85.3320A Boehringer Ingelheim Investigational Site
Paris, France
1160.85.3301A Boehringer Ingelheim Investigational Site
Paris cedex 10, France
1160.85.3302A Boehringer Ingelheim Investigational Site
Paris cedex 14, France
1160.85.3308A Boehringer Ingelheim Investigational Site
Pierre Bénite cedex, France
1160.85.3322A Boehringer Ingelheim Investigational Site
Poitiers Cédex, France
1160.85.3319A Boehringer Ingelheim Investigational Site
Saint Etienne Cédex 2, France
1160.85.3317A Boehringer Ingelheim Investigational Site
Saint Saulve, France
1160.85.3314A Boehringer Ingelheim Investigational Site
Toulouse Cedex 9, France
1160.85.3313A Boehringer Ingelheim Investigational Site
Toulouse Cédex 9, France
1160.85.3331A Boehringer Ingelheim Investigational Site
Vannes Cédex, France
Germany
1160.85.04924 Boehringer Ingelheim Investigational Site
Bad Homburg, Germany
1160.85.04926 Boehringer Ingelheim Investigational Site
Bayreuth, Germany
1160.85.04903 Boehringer Ingelheim Investigational Site
Berlin, Germany
1160.85.04931 Boehringer Ingelheim Investigational Site
Bochum, Germany
1160.85.04930 Boehringer Ingelheim Investigational Site
Breitenbrunn, Germany
1160.85.04923 Boehringer Ingelheim Investigational Site
Chemnitz, Germany
1160.85.04947 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1160.85.04945 Boehringer Ingelheim Investigational Site
Fürth, Germany
1160.85.04912 Boehringer Ingelheim Investigational Site
Garmische-Partenkirchen, Germany
1160.85.04922 Boehringer Ingelheim Investigational Site
Gelnhausen, Germany
1160.85.04917 Boehringer Ingelheim Investigational Site
Gelsenkirchen, Germany
1160.85.04949 Boehringer Ingelheim Investigational Site
Günzburg, Germany
1160.85.04927 Boehringer Ingelheim Investigational Site
Hachenburg, Germany
1160.85.04910 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1160.85.04906 Boehringer Ingelheim Investigational Site
Hannover, Germany
1160.85.04920 Boehringer Ingelheim Investigational Site
Hof, Germany
1160.85.04916 Boehringer Ingelheim Investigational Site
Kamp-Linfort, Germany
1160.85.04939 Boehringer Ingelheim Investigational Site
Kassel, Germany
1160.85.04929 Boehringer Ingelheim Investigational Site
Koblenz, Germany
1160.85.04909 Boehringer Ingelheim Investigational Site
Landstuhl, Germany
1160.85.04944 Boehringer Ingelheim Investigational Site
Lübben, Germany
1160.85.04935 Boehringer Ingelheim Investigational Site
Mainz, Germany
1160.85.04902 Boehringer Ingelheim Investigational Site
Marburg, Germany
1160.85.04934 Boehringer Ingelheim Investigational Site
Markgröningen, Germany
1160.85.04918 Boehringer Ingelheim Investigational Site
Marktheidenfeld, Germany
1160.85.04941 Boehringer Ingelheim Investigational Site
Merseburg, Germany
1160.85.04952 Boehringer Ingelheim Investigational Site
Minden, Germany
1160.85.04943 Boehringer Ingelheim Investigational Site
München, Germany
1160.85.04946 Boehringer Ingelheim Investigational Site
München, Germany
1160.85.04904 Boehringer Ingelheim Investigational Site
Nürnberg, Germany
1160.85.04913 Boehringer Ingelheim Investigational Site
Olsberg, Germany
1160.85.04932 Boehringer Ingelheim Investigational Site
Pfortzheim, Germany
1160.85.04901 Boehringer Ingelheim Investigational Site
Rosenheim, Germany
1160.85.04915 Boehringer Ingelheim Investigational Site
Rostock, Germany
1160.85.04928 Boehringer Ingelheim Investigational Site
Rostock, Germany
1160.85.04936 Boehringer Ingelheim Investigational Site
Rotenburg/Fulda, Germany
1160.85.04905 Boehringer Ingelheim Investigational Site
Schwarzenbruck, Germany
1160.85.04914 Boehringer Ingelheim Investigational Site
Sylt, Germany
1160.85.04933 Boehringer Ingelheim Investigational Site
Wertheim, Germany
1160.85.04921 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
1160.85.04938 Boehringer Ingelheim Investigational Site
Wismar, Germany
1160.85.04907 Boehringer Ingelheim Investigational Site
Worms, Germany
1160.85.04940 Boehringer Ingelheim Investigational Site
Würzburg, Germany
1160.85.04948 Boehringer Ingelheim Investigational Site
Würzburg, Germany
Ireland
1160.85.35301 Boehringer Ingelheim Investigational Site
Croom, Ireland
Italy
1160.85.03911 Boehringer Ingelheim Investigational Site
Bari, Italy
1160.85.03905 Boehringer Ingelheim Investigational Site
Firenze, Italy
1160.85.03904 Boehringer Ingelheim Investigational Site
Genova, Italy
1160.85.03906 Boehringer Ingelheim Investigational Site
Jesi (an), Italy
1160.85.03914 Boehringer Ingelheim Investigational Site
Latina, Italy
1160.85.03901 Boehringer Ingelheim Investigational Site
Mantova, Italy
1160.85.03913 Boehringer Ingelheim Investigational Site
Ome (bs), Italy
1160.85.03907 Boehringer Ingelheim Investigational Site
Roma, Italy
1160.85.03909 Boehringer Ingelheim Investigational Site
Torino, Italy
1160.85.03910 Boehringer Ingelheim Investigational Site
Vimercate (mi), Italy
Poland
1160.85.4805 Boehringer Ingelheim Investigational Site
Koscierzyna, Poland
1160.85.4804 Boehringer Ingelheim Investigational Site
Lodz, Poland
1160.85.4803 Boehringer Ingelheim Investigational Site
Otwock, Poland
1160.85.4802 Boehringer Ingelheim Investigational Site
Piekary Slaskie, Poland
1160.85.4806 Boehringer Ingelheim Investigational Site
Swiebodzin, Poland
Spain
1160.85.3404 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.85.3406 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.85.3405 Boehringer Ingelheim Investigational Site
Malaga, Spain
1160.85.3407 Boehringer Ingelheim Investigational Site
Pamplona, Spain
1160.85.3401 Boehringer Ingelheim Investigational Site
Valencia, Spain
1160.85.3402 Boehringer Ingelheim Investigational Site
Zaragoza, Spain
Sweden
1160.85.4603 Boehringer Ingelheim Investigational Site
Kungälv, Sweden
1160.85.4601 Boehringer Ingelheim Investigational Site
Motala, Sweden
1160.85.4604 Boehringer Ingelheim Investigational Site
Solleftea, Sweden
United Kingdom
1160.85.04405 Boehringer Ingelheim Investigational Site
Basildon, United Kingdom
1160.85.04406 Boehringer Ingelheim Investigational Site
Gateshead, United Kingdom
1160.85.04402 Boehringer Ingelheim Investigational Site
Halifax, United Kingdom
1160.85.04404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.85.04403 Boehringer Ingelheim Investigational Site
Luton, United Kingdom
1160.85.04401 Boehringer Ingelheim Investigational Site
Wigan, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00846807     History of Changes
Other Study ID Numbers: 1160.85
Study First Received: February 13, 2009
Results First Received: July 25, 2012
Last Updated: September 13, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
France: National Consultative Ethics Committee Health Life Sciences
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Medical Ethics Research Committee
Italy: Ethics Committee
Poland: Registration Medicinal Product Medical Device Biocidal Product
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Dabigatran
Anticoagulants
Antithrombins
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014