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

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00847301
First received: February 18, 2009
Last updated: April 2, 2014
Last verified: April 2014

February 18, 2009
April 2, 2014
April 2009
March 2015   (final data collection date for primary outcome measure)
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 ]
Safety: Major bleeding events. Efficacy: composite of all death and documented symptomatic VTE (i.e documented sympotomatic DVT and documented symptomatic nonfatal pulmonary embolism. [ Time Frame: up to 35 days ]
Complete list of historical versions of study NCT00847301 on ClinicalTrials.gov Archive Site
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 ]
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 ]
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Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Moderate renal insufficiency

  • Arthroplasty, Replacement
  • Thromboembolism
Not Provided
Renal Impairment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2015
March 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Austria,   France,   Germany,   Italy,   Spain,   Sweden,   United Kingdom
 
NCT00847301
1160.84
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP