Thromboembolism Clinical Trial
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.
| NCT number | NCT00846807 |
| Other study ID # | 1160.85 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | February 13, 2009 |
| Last updated | September 13, 2012 |
| Start date | February 2009 |
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
| Status | Completed |
| Enrollment | 5476 |
| Est. completion date | |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| Ireland | 1160.85.35301 Boehringer Ingelheim Investigational Site | Croom | |
| 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) | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Austria, France, Germany, Ireland, Italy, Poland, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | No |
| Secondary | 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 | Yes | |
| Secondary | Volume of Wound Drainage (Post-operative) | 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. | 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 | Yes |
| Secondary | 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 | No |
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