NCT03475771

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 12, 2018

Last Update Submit

March 26, 2018

Conditions

Venous ThromboembolismPelvic Fracture

Outcome Measures

Primary Outcomes (1)

  • number of venous thrombo-embolic events

    Month 1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • indication to pelvic fracture surgery
  • age above 18 years

You may not qualify if:

  • pelvic fracture without surgery indication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Venous ThromboembolismHip Fractures

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • BONHOMME Stéphanie, MD

    GHPSJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 23, 2018

Study Start

March 24, 2017

Primary Completion

December 31, 2017

Study Completion

January 4, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

FR(1)