Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery

March 26, 2018 updated by: Groupe Hospitalier Paris Saint Joseph

Pelvic fracture are very often treated by surgery ; however there are a high level of thrombotic risk during the surgery (venous thrombo embolic events represent about 10% to 50%.

The aim of our study is to report the number of these events and identify the risk factor associated to these events regarding Greenfield Risk Assessment Profile .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

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

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients admitted in GHPSJ orthopedy yard between december 2014 and january 2017

Description

Inclusion Criteria:

  • indication to pelvic fracture surgery
  • age above 18 years

Exclusion Criteria:

  • pelvic fracture without surgery indication.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of venous thrombo-embolic events
Time Frame: Month 1
Month 1

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: BONHOMME Stéphanie, MD, GHPSJ

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)

March 24, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 4, 2018

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTEVbassin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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