Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Arthroplasty, Replacement

Thromboembolism

Eligibility:

All Genders

18-75 years

Brief Summary

An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study
  • Exclusion criteria:
  • All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of \> 75 years, renal impairment (creatinine clearance \<50 ml/min), patients with concomitant therapy of amiodarone, elevated liver enzymes \> 2 upper limit of normal (ULN) and/or 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 except for the above included patients groups, concomitant treatment with quinidine

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    5476 Patients enrolled

    Trial Details

    Trial ID

    NCT00846807

    Start Date

    February 1 2009

    Last Update

    September 18 2012

    Active Locations (112)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 28 (112 locations)

    1

    1160.85.4308 Boehringer Ingelheim Investigational Site

    Graz, Austria

    2

    1160.85.4309 Boehringer Ingelheim Investigational Site

    Klagenfurt, Austria

    3

    1160.85.4303 Boehringer Ingelheim Investigational Site

    Linz, Austria

    4

    1160.85.4304 Boehringer Ingelheim Investigational Site

    Linz, Austria