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

August 25, 2015 updated by: Boehringer Ingelheim

Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

472

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • 1160.84.4301 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.84.4310 Boehringer Ingelheim Investigational Site
  • France
      • Angers, France
        • 1160.84.3311 Boehringer Ingelheim Investigational Site
      • Bordeaux, France
        • 1160.84.3334 Boehringer Ingelheim Investigational Site
      • Caen Cedex 5, France
        • 1160.84.3303 Boehringer Ingelheim Investigational Site
      • Clermont-Ferrand cedex 1, France
        • 1160.84.3314 Boehringer Ingelheim Investigational Site
      • Creteil, France
        • 1160.84.3320 Boehringer Ingelheim Investigational Site
      • DIJON Cédex, France
        • 1160.84.3307 Boehringer Ingelheim Investigational Site
      • Illkirch, France
        • 1160.84.3310 Boehringer Ingelheim Investigational Site
      • Le Havre, France
        • 1160.84.3335 Boehringer Ingelheim Investigational Site
      • Les Lilas, France
        • 1160.84.3326 Boehringer Ingelheim Investigational Site
      • Lyon, France
        • 1160.84.3312 Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1160.84.3305 Boehringer Ingelheim Investigational Site
      • Nantes Cédex 2, France
        • 1160.84.3323 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1160.84.3302 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1160.84.3306 Boehringer Ingelheim Investigational Site
      • Pierre Bénite cedex, France
        • 1160.84.3313 Boehringer Ingelheim Investigational Site
      • Poitiers Cédex, France
        • 1160.84.3324 Boehringer Ingelheim Investigational Site
      • Saint Etienne Cédex 2, France
        • 1160.84.3322 Boehringer Ingelheim Investigational Site
      • Saint Saulve, France
        • 1160.84.3319 Boehringer Ingelheim Investigational Site
      • Toulouse Cédex 9, France
        • 1160.84.3316 Boehringer Ingelheim Investigational Site
      • Vannes Cédex, France
        • 1160.84.3332 Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1160.84.04903 Boehringer Ingelheim Investigational Site
      • Erlangen, Germany
        • 1160.84.04947 Boehringer Ingelheim Investigational Site
      • Gelnhausen, Germany
        • 1160.84.4922 Boehringer Ingelheim Investigational Site
      • Hachenburg, Germany
        • 1160.84.04927 Boehringer Ingelheim Investigational Site
      • Koblenz, Germany
        • 1160.84.04929 Boehringer Ingelheim Investigational Site
      • Marburg, Germany
        • 1160.84.04902 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1160.84.04946 Boehringer Ingelheim Investigational Site
      • Olsberg, Germany
        • 1160.84.04913 Boehringer Ingelheim Investigational Site
      • Sylt, Germany
        • 1160.84.04914 Boehringer Ingelheim Investigational Site
      • Wismar, Germany
        • 1160.84.04938 Boehringer Ingelheim Investigational Site
      • Würzburg, Germany
        • 1160.84.04948 Boehringer Ingelheim Investigational Site
  • Italy
      • Latina, Italy
        • 1160.84.03908 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1160.84.03902 Boehringer Ingelheim Investigational Site
      • Monza, Italy
        • 1160.84.03904 Boehringer Ingelheim Investigational Site
      • Udine, Italy
        • 1160.84.03909 Boehringer Ingelheim Investigational Site
  • Spain
      • Badalona (Barcelona), Spain
        • 1160.84.3409 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1160.84.3410 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1160.84.3403 Boehringer Ingelheim Investigational Site
      • Malaga, Spain
        • 1160.84.3405 Boehringer Ingelheim Investigational Site
      • Pamplona, Spain
        • 1160.84.3404 Boehringer Ingelheim Investigational Site
      • Pozuelo de Alarcón - Madrid, Spain
        • 1160.84.3412 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1160.84.3401 Boehringer Ingelheim Investigational Site
      • Zaragoza, Spain
        • 1160.84.3402 Boehringer Ingelheim Investigational Site
  • Sweden
      • Kungälv, Sweden
        • 1160.84.4603 Boehringer Ingelheim Investigational Site
      • Motala, Sweden
        • 1160.84.4601 Boehringer Ingelheim Investigational Site
      • Sollefteå, Sweden
        • 1160.84.4604 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Basildon, United Kingdom
        • 1160.84.04405 Boehringer Ingelheim Investigational Site
      • Bedford, United Kingdom
        • 1160.84.04408 Boehringer Ingelheim Investigational Site
      • Luton, United Kingdom
        • 1160.84.04403 Boehringer Ingelheim Investigational Site
      • Wigan, United Kingdom
        • 1160.84.04401 Boehringer Ingelheim Investigational Site
      • Yeovil, United Kingdom
        • 1160.84.04407 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Moderate renal insufficiency

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Renal Impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Major Bleeding Events (MBE)
Time Frame: 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
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 Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
Time Frame: 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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
Time Frame: 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
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
Time Frame: 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
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 (Post-operative)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.84

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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