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

January 21, 2025 updated by: Boehringer Ingelheim

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.

Open, prospective, uncontrolled, observational cohort study.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • 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 1
      • Distrito Federal, Mexico
        • Boehringer Ingelheim Investigational Site 20
      • 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
      • Guadalajara, 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
      • Monterrey, Mexico
        • Boehringer Ingelheim Investigational Site 28
      • Puebla, Mexico
        • Boehringer Ingelheim Investigational Site 26
      • Puebla, Mexico
        • Boehringer Ingelheim Investigational Site 27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Venous Thromboembolic Events
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Major Bleeding Events (MBE)
Time Frame: From 12 To 37 Days
From 12 To 37 Days
Major Extra Surgical Site Bleedings
Time Frame: From 12 To 37 Days
From 12 To 37 Days
Volume of Wound Drainage
Time Frame: From 12 To 37 Days
From 12 To 37 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimated)

August 27, 2009

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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