Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
- Conditions
- Arthroplasty, Replacement, HipThromboembolism
- Interventions
- Registration Number
- NCT00168818
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3494
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dabigatran etexilate 75 mg dabigatran etexilate daily dose 150 mg once daily, half a dose on the day of surgery dabigatran etexilate 110 mg dabigatran etexilate daily dose 220 mg once daily, half a dose on the day of surgery enoxaparin enoxaparin 40 mg once daily
- Primary Outcome Measures
Name Time Method Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period First administration until 31-38 days Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
- Secondary Outcome Measures
Name Time Method Death During Treatment Period First administration until 31-38 days All cause death, as adjudicated by the VTE events committee
Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period First administration until 31-38 days Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Proximal Deep Vein Thrombosis During Treatment Period First administration until 31-38 days Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Total Deep Vein Thrombosis During Treatment Period First administration until 31-38 days Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Symptomatic Deep Vein Thrombosis During Treatment Period First administration until 31-38 days Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Pulmonary Embolism During Treatment Period First administration until 31-38 days Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period end of treatment to day 91±7 Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period First administration until 31-38 days Major bleeding events were defined as
* 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
Clinically-relevant was defined as
* spontaneous skin hematoma greater than or equal to 25 cm²
* wound hematoma greater than or equal to 100 cm²
* spontaneous nose bleed lasting longer than 5 min
* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
* spontaneous rectal bleeding (more than a spot on toilet paper)
* gingival bleeding lasting longer than 5 min
* any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.Blood Transfusion Day 1 Blood transfusion for treated and operated patients on Day of surgery.
Volume of Blood Loss Day 1 Volume of blood loss for treated and operated patients during surgery.
Laboratory Analyses First administration to end of study Frequency of patients with possible clinically significant abnormalities.
Related Research Topics
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Trial Locations
- Locations (116)
1160.48.06102 Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
1160.48.06104 Ecru
🇦🇺Box Hill, Victoria, Australia
1160.48.06110 Suite 13 level 4
🇦🇺Lismore, New South Wales, Australia
1160.48.04301 Boehringer Ingelheim Investigational Site
🇦🇹Wr. Neustadt, Austria
1160.48.06108 Canberra Hospital
🇦🇺Garren, Australian Capital Territory, Australia
1160.48.06105 Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
1160.48.42009 Boehringer Ingelheim Investigational Site
🇨🇿Havlickuv Brod, Czech Republic
1160.48.42003 Boehringer Ingelheim Investigational Site
🇨🇿Ostrava, Czech Republic
1160.48.03202 Boehringer Ingelheim Investigational Site
🇧🇪Hasselt, Belgium
1160.48.03205 Ziekenhuis Oost-Limburg
🇧🇪Lanaken, Belgium
1160.48.02701 Boehringer Ingelheim Investigational Site
🇿🇦Bryanston, South Africa
1160.48.02703 Boehringer Ingelheim Investigational Site
🇿🇦Randburg, South Africa
1160.48.35804 Boehringer Ingelheim Investigational Site
🇫🇮Seinäjoki, Finland
1160.48.42004 Boehringer Ingelheim Investigational Site
🇨🇿Brno-Bohunice, Czech Republic
1160.48.42001 Boehringer Ingelheim Investigational Site
🇨🇿Plzen, Czech Republic
1160.48.35805 Boehringer Ingelheim Investigational Site
🇫🇮Tampere, Finland
1160.48.04701 Boehringer Ingelheim Investigational Site
🇳🇴Bodø, Norway
1160.48.04707 Boehringer Ingelheim Investigational Site
🇳🇴Bærum Postterminal, Norway
1160.48.03107 Boehringer Ingelheim Investigational Site
🇳🇱Helmond, Netherlands
1160.48.03303 Boehringer Ingelheim Investigational Site
🇫🇷Roubaix cedex, France
1160.48.04804 Boehringer Ingelheim Investigational Site
🇵🇱Kielce, Poland
1160.48.03603 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1160.48.03606 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1160.48.04703 Boehringer Ingelheim Investigational Site
🇳🇴Ålesund, Norway
1160.48.04907 Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
1160.48.04904 Orthopädische Universitätsklinik
🇩🇪Frankfurt, Germany
1160.48.04915 Orthopädische Klinik Lindenlohe
🇩🇪Schwandorf, Germany
1160.48.04910 F.-A.-Universität Erlangen-Nürnberg
🇩🇪Erlangen, Germany
1160.48.04704 Boehringer Ingelheim Investigational Site
🇳🇴Bærum Postterminal, Norway
1160.48.04706 Boehringer Ingelheim Investigational Site
🇳🇴Elverum, Norway
1160.48.04810 Boehringer Ingelheim Investigational Site
🇵🇱Bialystok, Poland
1160.48.04607 Boehringer Ingelheim Investigational Site
🇸🇪Halmstad, Sweden
1160.48.03401 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.48.03404 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.48.04806 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.48.04812 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.48.04609 Boehringer Ingelheim Investigational Site
🇸🇪Varberg, Sweden
1160.48.03410 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1160.48.03402 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.48.03406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.48.03407 Boehringer Ingelheim Investigational Site
🇪🇸Hospitalet (Barcelona), Spain
1160.48.02702 Boehringer Ingelheim Investigational Site
🇿🇦Sandton, South Africa
1160.48.04817 Boehringer Ingelheim Investigational Site
🇵🇱Rzeszow, Poland
1160.48.04606 Boehringer Ingelheim Investigational Site
🇸🇪Kalmar, Sweden
1160.48.04605 Boehringer Ingelheim Investigational Site
🇸🇪Linköping, Sweden
1160.48.02704 Boehringer Ingelheim Investigational Site
🇿🇦Johannesburg, South Africa
1160.48.03405 Boehringer Ingelheim Investigational Site
🇪🇸Alcorcón (Madrid), Spain
1160.48.03408 Boehringer Ingelheim Investigational Site
🇪🇸Móstoles (Madrid), Spain
1160.48.04608 Boehringer Ingelheim Investigational Site
🇸🇪Lidköping, Sweden
1160.48.04610 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.48.03403 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.48.42010 Boehringer Ingelheim Investigational Site
🇨🇿Chomutov, Czech Republic
1160.48.04304 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.48.42007 Boehringer Ingelheim Investigational Site
🇨🇿Pradubice, Czech Republic
1160.48.03102 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.48.03101 Boehringer Ingelheim Investigational Site
🇳🇱Heemstede, Netherlands
1160.48.03103 Boehringer Ingelheim Investigational Site
🇳🇱Hilversum, Netherlands
1160.48.03104 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
1160.48.03105 Boehringer Ingelheim Investigational Site
🇳🇱Sittard, Netherlands
1160.48.42006 Boehringer Ingelheim Investigational Site
🇨🇿Kolin, Czech Republic
1160.48.42005 Boehringer Ingelheim Investigational Site
🇨🇿Prague 8, Czech Republic
1160.48.04801 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.48.35803 Boehringer Ingelheim Investigational Site
🇫🇮Helsinki, Finland
1160.48.35801 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
1160.48.04702 Boehringer Ingelheim Investigational Site
🇳🇴Skien, Norway
1160.48.04814 Boehringer Ingelheim Investigational Site
🇵🇱Mielec, Poland
1160.48.04807 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.48.04820 Boehringer Ingelheim Investigational Site
🇵🇱Lodz, Poland
1160.48.04802 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.48.04808 Boehringer Ingelheim Investigational Site
🇵🇱Piekary Slaskie, Poland
1160.48.04803 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.48.04571 Boehringer Ingelheim Investigational Site
🇩🇰Hellerup, Denmark
1160.48.04570 Boehringer Ingelheim Investigational Site
🇩🇰Hørsholm, Denmark
1160.48.04573 Boehringer Ingelheim Investigational Site
🇩🇰København NV, Denmark
1160.48.04575 Boehringer Ingelheim Investigational Site
🇩🇰Silkeborg, Denmark
1160.48.04601 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.48.04604 Boehringer Ingelheim Investigational Site
🇸🇪Mölndal, Sweden
1160.48.03302 Boehringer Ingelheim Investigational Site
🇫🇷Soyaux, France
1160.48.04905 Aukammklinik
🇩🇪Wiesbaden, Germany
1160.48.06106 St George Public Hospital
🇦🇺Kogarah, New South Wales, Australia
1160.48.06103 Maroondah Hospital
🇦🇺Ringwood East, Victoria, Australia
1160.48.06113
🇦🇺Windsor, Victoria, Australia
1160.48.06111 Haemophillia & Thrombosis Service
🇦🇺Perth, Western Australia, Australia
1160.48.04302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.48.04303 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
1160.48.03206 Campus Sint-Lucas
🇧🇪Gent, Belgium
1160.48.03207 UVC Brugmann
🇧🇪Brussels, Belgium
1160.48.03203 AZ Sint Elisabeth
🇧🇪Herentals, Belgium
1160.48.03208 UZ Gent
🇧🇪Gent, Belgium
1160.48.03201 UZ Gasthuisberg
🇧🇪Leuven, Belgium
1160.48.42002 Boehringer Ingelheim Investigational Site
🇨🇿Kladno, Czech Republic
1160.48.42008 Boehringer Ingelheim Investigational Site
🇨🇿Jihlava, Czech Republic
1160.48.04574 Boehringer Ingelheim Investigational Site
🇩🇰København S, Denmark
1160.48.35802 Boehringer Ingelheim Investigational Site
🇫🇮Jyväskylä, Finland
1160.48.03304 Boehringer Ingelheim Investigational Site
🇫🇷Amiens cedex 1, France
1160.48.03308 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1160.48.04906 Caritaskrankenhaus
🇩🇪Bad Mergentheim, Germany
1160.48.04902 Klinikum Garmisch-Partenkirchen
🇩🇪Garmisch-Partenkirchen, Germany
1160.48.04912 Orthopädische Klinik Markgröningen gGmbH
🇩🇪Markgröningen, Germany
1160.48.04901 Kreiskrankenhaus
🇩🇪Rheinfelden, Germany
1160.48.04914 St. Bernhard-Hospital
🇩🇪Kamp-Lintfort, Germany
1160.48.03607 Boehringer Ingelheim Investigational Site
🇭🇺Békéscsaba, Hungary
1160.48.03604 Boehringer Ingelheim Investigational Site
🇭🇺Kecskemét, Hungary
1160.48.03601 Boehringer Ingelheim Investigational Site
🇭🇺Gyula, Hungary
1160.48.04903 Hellmuth-Ulrici-Kliniken
🇩🇪Sommerfeld, Germany
1160.48.03605 Boehringer Ingelheim Investigational Site
🇭🇺Székesfehérvár, Hungary
1160.48.03602 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
1160.48.03903 Boehringer Ingelheim Investigational Site
🇮🇹Bergamo, Italy
1160.48.03902 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1160.48.03904 Boehringer Ingelheim Investigational Site
🇮🇹Bologna, Italy
1160.48.03901 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1160.48.03411 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.48.04602 Boehringer Ingelheim Investigational Site
🇸🇪Falköping, Sweden
1160.48.04603 Boehringer Ingelheim Investigational Site
🇸🇪Kungälv, Sweden
1160.48.06101 Emeritus Research
🇦🇺Malvern, Victoria, Australia
1160.48.03409 Boehringer Ingelheim Investigational Site
🇪🇸Jaén, Spain