Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00967447
First received: August 13, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

Open, prospective, uncontrolled, observational cohort study.


Condition
Thromboembolism
Arthroplasty, Replacement, Hip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Venous Thromboembolic Events [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Bleeding Events (MBE) [ Time Frame: From 12 To 37 Days ] [ Designated as safety issue: Yes ]
  • Major Extra Surgical Site Bleedings [ Time Frame: From 12 To 37 Days ] [ Designated as safety issue: Yes ]
  • Volume of Wound Drainage [ Time Frame: From 12 To 37 Days ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: February 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinics

Criteria

Inclusion criteria:

  • patients age 18 years or above undergoing elective total hip or knee replacement surgery
  • Written informed consent obtained for data collection and source data verification.

Exclusion criteria:

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:

  • age of > 75 years
  • renal impairment (creatinine clearance <50ml/min)
  • patients on concomitant therapy with amiodarone or verapamil.
  • 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
  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: NCT00967447

Locations
Mexico
Boehringer Ingelheim Investigational Site 1
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 2
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 3
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 4
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 5
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 6
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 7
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 8
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 9
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 10
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 11
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 12
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 13
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 14
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 15
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 16
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 17
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 18
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 19
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 20
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site 21
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 22
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 23
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 24
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 25
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site 28
Monterrey, Mexico
Boehringer Ingelheim Investigational Site 26
Puebla, Mexico
Boehringer Ingelheim Investigational Site 27
Puebla, Mexico
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00967447     History of Changes
Other Study ID Numbers: 1160.103
Study First Received: August 13, 2009
Results First Received: January 5, 2012
Last Updated: February 24, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 20, 2014