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

Completed
Conditions
Arthroplasty, Replacement
Thromboembolism
Registration Number
NCT00846807
Lead Sponsor
Boehringer Ingelheim
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5476
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Patients With Major Bleeding Events (MBE) During Treatment PeriodFrom 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 MortalityFrom 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).

Secondary Outcome Measures
NameTimeMethod
Percentage of Patients With Major Extra-surgical Site BleedingsFrom 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 Single Components of Composite of sVTE and All-cause MortalityFrom 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 (Post-operative)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

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.

Trial Locations

Locations (112)

1160.85.4308 Boehringer Ingelheim Investigational Site

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Graz, Austria

1160.85.4309 Boehringer Ingelheim Investigational Site

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Klagenfurt, Austria

1160.85.4303 Boehringer Ingelheim Investigational Site

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Linz, Austria

1160.85.4304 Boehringer Ingelheim Investigational Site

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Linz, Austria

1160.85.4305 Boehringer Ingelheim Investigational Site

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St. Johann/Tirol, Austria

1160.85.4312 Boehringer Ingelheim Investigational Site

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Stolzalpe, Austria

1160.85.4307 Boehringer Ingelheim Investigational Site

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Wels, Austria

1160.85.4301 Boehringer Ingelheim Investigational Site

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Wien, Austria

1160.85.4302 Boehringer Ingelheim Investigational Site

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Wien, Austria

1160.85.4310 Boehringer Ingelheim Investigational Site

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Wien, Austria

Scroll for more (102 remaining)
1160.85.4308 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria

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