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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00847301
First received: February 18, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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


Condition
Arthroplasty, Replacement
Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Safety: Major bleeding events. Efficacy: composite of all death and documented symptomatic VTE (i.e documented symptomatic DVT and documented symptomatic nonfatal pulmonary embolism). [ Time Frame: up to 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major extra surgical site bleedings,volume of wound drainage, documented symptomatic proximal DVT, documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality [ Time Frame: up to 35 days ] [ Designated as safety issue: Yes ]

Enrollment: 482
Study Start Date: April 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Renal Impairment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Moderate renal insufficiency

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847301

  Hide Study Locations
Locations
Austria
1160.84.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
1160.84.4310 Boehringer Ingelheim Investigational Site
Wien, Austria
France
1160.84.3311 Boehringer Ingelheim Investigational Site
Angers, France
1160.84.3318 Boehringer Ingelheim Investigational Site
Bois Guillaume Cédex, France
1160.84.3334 Boehringer Ingelheim Investigational Site
Bordeaux, France
1160.84.3303 Boehringer Ingelheim Investigational Site
Caen Cedex 5, France
1160.84.3314 Boehringer Ingelheim Investigational Site
Clermont-Ferrand cedex 1, France
1160.84.3320 Boehringer Ingelheim Investigational Site
Creteil, France
1160.84.3307 Boehringer Ingelheim Investigational Site
DIJON Cédex, France
1160.84.3310 Boehringer Ingelheim Investigational Site
Illkirch, France
1160.84.3335 Boehringer Ingelheim Investigational Site
Le Havre, France
1160.84.3326 Boehringer Ingelheim Investigational Site
Les Lilas, France
1160.84.3304 Boehringer Ingelheim Investigational Site
Lille cedex, France
1160.84.3312 Boehringer Ingelheim Investigational Site
Lyon, France
1160.84.3305 Boehringer Ingelheim Investigational Site
Marseille, France
1160.84.3330 Boehringer Ingelheim Investigational Site
MARSEILLE Cédex 05, France
1160.84.3325 Boehringer Ingelheim Investigational Site
Metz, France
1160.84.3333 Boehringer Ingelheim Investigational Site
Montauban, France
1160.84.3323 Boehringer Ingelheim Investigational Site
Nantes Cédex 2, France
1160.84.3306 Boehringer Ingelheim Investigational Site
Paris, France
1160.84.3302 Boehringer Ingelheim Investigational Site
Paris, France
1160.84.3327 Boehringer Ingelheim Investigational Site
Paris, France
1160.84.3309 Boehringer Ingelheim Investigational Site
Paris cedex 10, France
1160.84.3313 Boehringer Ingelheim Investigational Site
Pierre Bénite cedex, France
1160.84.3324 Boehringer Ingelheim Investigational Site
Poitiers Cédex, France
1160.84.3322 Boehringer Ingelheim Investigational Site
Saint Etienne Cédex 2, France
1160.84.3321 Boehringer Ingelheim Investigational Site
Saint Herblain Cédex, France
1160.84.3319 Boehringer Ingelheim Investigational Site
Saint Saulve, France
1160.84.3317 Boehringer Ingelheim Investigational Site
Toulouse Cedex 9, France
1160.84.3316 Boehringer Ingelheim Investigational Site
Toulouse Cédex 9, France
1160.84.3332 Boehringer Ingelheim Investigational Site
Vannes Cédex, France
Germany
1160.84.04903 Boehringer Ingelheim Investigational Site
Berlin, Germany
1160.84.04947 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1160.84.4922 Boehringer Ingelheim Investigational Site
Gelnhausen, Germany
1160.84.04927 Boehringer Ingelheim Investigational Site
Hachenburg, 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
1160.84.04913 Boehringer Ingelheim Investigational Site
Olsberg, Germany
1160.84.04914 Boehringer Ingelheim Investigational Site
Sylt, Germany
1160.84.04938 Boehringer Ingelheim Investigational Site
Wismar, Germany
1160.84.04948 Boehringer Ingelheim Investigational Site
Würzburg, Germany
Italy
1160.84.03908 Boehringer Ingelheim Investigational Site
Latina, Italy
1160.84.03902 Boehringer Ingelheim Investigational Site
Milano, Italy
1160.84.03904 Boehringer Ingelheim Investigational Site
Monza, Italy
1160.84.03909 Boehringer Ingelheim Investigational Site
Udine, Italy
Spain
1160.84.3409 Boehringer Ingelheim Investigational Site
Badalona (Barcelona), Spain
1160.84.3410 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.84.3413 Boehringer Ingelheim Investigational Site
Linares, Jaén, Spain
1160.84.3403 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.84.3408 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.84.3405 Boehringer Ingelheim Investigational Site
Malaga, Spain
1160.84.3404 Boehringer Ingelheim Investigational Site
Pamplona, Spain
1160.84.3412 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón - Madrid, Spain
1160.84.3401 Boehringer Ingelheim Investigational Site
Valencia, Spain
1160.84.3411 Boehringer Ingelheim Investigational Site
Valencia, Spain
1160.84.3402 Boehringer Ingelheim Investigational Site
Zaragoza, Spain
Sweden
1160.84.4603 Boehringer Ingelheim Investigational Site
Kungälv, Sweden
1160.84.4601 Boehringer Ingelheim Investigational Site
Motala, Sweden
1160.84.4604 Boehringer Ingelheim Investigational Site
Sollefteå, Sweden
United Kingdom
1160.84.04405 Boehringer Ingelheim Investigational Site
Basildon, United Kingdom
1160.84.04408 Boehringer Ingelheim Investigational Site
Bedford, United Kingdom
1160.84.04403 Boehringer Ingelheim Investigational Site
Luton, United Kingdom
1160.84.04401 Boehringer Ingelheim Investigational Site
Wigan, United Kingdom
1160.84.04407 Boehringer Ingelheim Investigational Site
Yeovil, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00847301     History of Changes
Other Study ID Numbers: 1160.84
Study First Received: February 18, 2009
Last Updated: July 23, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Renal Insufficiency
Thromboembolism
Kidney Diseases
Urologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on July 26, 2014