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

Completed

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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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

Locations (53): 1160.84.4301 Boehringer Ingelheim Investigational Site
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Wien, Austria
1160.84.4310 Boehringer Ingelheim Investigational Site
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Wien, Austria
1160.84.3311 Boehringer Ingelheim Investigational Site
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Angers, France
1160.84.3334 Boehringer Ingelheim Investigational Site
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Bordeaux, France
1160.84.3303 Boehringer Ingelheim Investigational Site
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Caen Cedex 5, France
1160.84.3314 Boehringer Ingelheim Investigational Site
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Clermont-Ferrand cedex 1, France
1160.84.3320 Boehringer Ingelheim Investigational Site
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Creteil, France
1160.84.3307 Boehringer Ingelheim Investigational Site
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DIJON Cédex, France
1160.84.3310 Boehringer Ingelheim Investigational Site
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Illkirch, France
1160.84.3335 Boehringer Ingelheim Investigational Site
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Le Havre, France
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1160.84.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria