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

  Show 65 Study Locations
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:
Thromboembolism
Renal Insufficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Kidney Diseases
Urologic Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014