Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

Completed

• Conditions: Thromboembolism; Arthroplasty, Replacement

• Registration Number: NCT00847301
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Study Start: 2009-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-06-30
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-25
• Last Update Submitted: 2015-08-25
• Results First Posted: 2015-09-25
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Major Bleeding Events (MBE)	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	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	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	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) and All Cause Mortality.

Secondary Outcome Measures

Name	Time	Method
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism 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	Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality
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	Percentage of Patients With Major Extra-surgical Site Bleedings
Volume of Wound Drainage (Post-operative)	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 after surgery

Trial Locations

Locations (53)

1160.84.04938 Boehringer Ingelheim Investigational Site; 🇩🇪 Wismar, Germany

1160.84.4603 Boehringer Ingelheim Investigational Site; 🇸🇪 Kungälv, Sweden

1160.84.04407 Boehringer Ingelheim Investigational Site; 🇬🇧 Yeovil, United Kingdom

1160.84.3334 Boehringer Ingelheim Investigational Site; 🇫🇷 Bordeaux, France

1160.84.3322 Boehringer Ingelheim Investigational Site; 🇫🇷 Saint Etienne Cédex 2, France

1160.84.3332 Boehringer Ingelheim Investigational Site; 🇫🇷 Vannes Cédex, France

1160.84.3320 Boehringer Ingelheim Investigational Site; 🇫🇷 Creteil, France

1160.84.04927 Boehringer Ingelheim Investigational Site; 🇩🇪 Hachenburg, Germany

1160.84.03909 Boehringer Ingelheim Investigational Site; 🇮🇹 Udine, Italy

1160.84.3306 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

1160.84.3311 Boehringer Ingelheim Investigational Site; 🇫🇷 Angers, France

1160.84.3326 Boehringer Ingelheim Investigational Site; 🇫🇷 Les Lilas, France

1160.84.3323 Boehringer Ingelheim Investigational Site; 🇫🇷 Nantes Cédex 2, France

1160.84.3313 Boehringer Ingelheim Investigational Site; 🇫🇷 Pierre Bénite cedex, France

1160.84.3324 Boehringer Ingelheim Investigational Site; 🇫🇷 Poitiers Cédex, France

1160.84.4922 Boehringer Ingelheim Investigational Site; 🇩🇪 Gelnhausen, Germany

1160.84.04929 Boehringer Ingelheim Investigational Site; 🇩🇪 Koblenz, Germany

1160.84.04902 Boehringer Ingelheim Investigational Site; 🇩🇪 Marburg, Germany

1160.84.04946 Boehringer Ingelheim Investigational Site; 🇩🇪 München, Germany

1160.84.3314 Boehringer Ingelheim Investigational Site; 🇫🇷 Clermont-Ferrand cedex 1, France

1160.84.3310 Boehringer Ingelheim Investigational Site; 🇫🇷 Illkirch, France

1160.84.3319 Boehringer Ingelheim Investigational Site; 🇫🇷 Saint Saulve, France

1160.84.3316 Boehringer Ingelheim Investigational Site; 🇫🇷 Toulouse Cédex 9, France

1160.84.04947 Boehringer Ingelheim Investigational Site; 🇩🇪 Erlangen, Germany

1160.84.04913 Boehringer Ingelheim Investigational Site; 🇩🇪 Olsberg, Germany

1160.84.04914 Boehringer Ingelheim Investigational Site; 🇩🇪 Sylt, Germany

1160.84.03904 Boehringer Ingelheim Investigational Site; 🇮🇹 Monza, Italy

1160.84.04903 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1160.84.4301 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1160.84.3303 Boehringer Ingelheim Investigational Site; 🇫🇷 Caen Cedex 5, France

1160.84.3335 Boehringer Ingelheim Investigational Site; 🇫🇷 Le Havre, France

1160.84.3305 Boehringer Ingelheim Investigational Site; 🇫🇷 Marseille, France

1160.84.04948 Boehringer Ingelheim Investigational Site; 🇩🇪 Würzburg, Germany

1160.84.03908 Boehringer Ingelheim Investigational Site; 🇮🇹 Latina, Italy

1160.84.3312 Boehringer Ingelheim Investigational Site; 🇫🇷 Lyon, France

1160.84.4310 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1160.84.3307 Boehringer Ingelheim Investigational Site; 🇫🇷 DIJON Cédex, France

1160.84.3302 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

1160.84.3409 Boehringer Ingelheim Investigational Site; 🇪🇸 Badalona (Barcelona), Spain

1160.84.3401 Boehringer Ingelheim Investigational Site; 🇪🇸 Valencia, Spain

1160.84.03902 Boehringer Ingelheim Investigational Site; 🇮🇹 Milano, Italy

1160.84.3404 Boehringer Ingelheim Investigational Site; 🇪🇸 Pamplona, Spain

1160.84.4604 Boehringer Ingelheim Investigational Site; 🇸🇪 Sollefteå, Sweden

1160.84.04405 Boehringer Ingelheim Investigational Site; 🇬🇧 Basildon, United Kingdom

1160.84.04403 Boehringer Ingelheim Investigational Site; 🇬🇧 Luton, United Kingdom

1160.84.04401 Boehringer Ingelheim Investigational Site; 🇬🇧 Wigan, United Kingdom

1160.84.3410 Boehringer Ingelheim Investigational Site; 🇪🇸 Barcelona, Spain

1160.84.3412 Boehringer Ingelheim Investigational Site; 🇪🇸 Pozuelo de Alarcón - Madrid, Spain

1160.84.4601 Boehringer Ingelheim Investigational Site; 🇸🇪 Motala, Sweden

1160.84.3403 Boehringer Ingelheim Investigational Site; 🇪🇸 Madrid, Spain

1160.84.3405 Boehringer Ingelheim Investigational Site; 🇪🇸 Malaga, Spain

1160.84.3402 Boehringer Ingelheim Investigational Site; 🇪🇸 Zaragoza, Spain

1160.84.04408 Boehringer Ingelheim Investigational Site; 🇬🇧 Bedford, United Kingdom