Status:
COMPLETED
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Arthroplasty, Replacement
Thromboembolism
Eligibility:
All Genders
18+ years
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
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study
- Exclusion criteria:
- All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):
- severe renal impairment (creatinine clearance \< 30 ml/min); elevated liver enzymes \> 2 upper limit of normal (ULN); 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, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT00847301
Start Date
April 1 2009
End Date
July 1 2014
Last Update
September 25 2015
Active Locations (53)
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1
1160.84.4301 Boehringer Ingelheim Investigational Site
Vienna, Austria
2
1160.84.4310 Boehringer Ingelheim Investigational Site
Vienna, Austria
3
1160.84.3311 Boehringer Ingelheim Investigational Site
Angers, France
4
1160.84.3334 Boehringer Ingelheim Investigational Site
Bordeaux, France