NCT03535428

Brief Summary

Pelvic fracture surgery are very high thrombotic risk surgery with about 10% to 50% venous thrombo embolic complications and 0.5% to 10% of pulmonary embolism. The ST JOSEPH's Hospital have almost 60 cases per year . Following a fatal pulmonary embolism per operatory the team has set up a venous exploratory protocol before surgery. This protocol includes a venous doppler ultrasound of lower limbs associated to a abdo pelvic scanner in the 48hours before surgery. The aim is to evaluate this new protocol efficacy on prevention of thrombo embolic complications in pelvic fracture surgery.

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 Feb 2017

Typical duration 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

February 13, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 3, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

May 11, 2018

Last Update Submit

October 2, 2019

Conditions

Venous ThromboembolismPelvic Surgery

Outcome Measures

Primary Outcomes (1)

  • major thrombo-embolic events

    Day 10 after surgery

Study Arms (1)

VENOUS exploration

Diagnostic Test: VENOUS exploration

Interventions

VENOUS explorationDIAGNOSTIC_TEST

venous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery

VENOUS exploration

Eligibility Criteria

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

patient with pelvic surgery indication consulting surgeons

You may qualify if:

  • pelvic fracture with surgery indication
  • 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 Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • BONHOMME Stéphanie, MD

    GHPSJ

    PRINCIPAL INVESTIGATOR

  • RIOUALLON Guillaume, MD

    GHPSJ

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 24, 2018

Study Start

February 13, 2017

Primary Completion

April 25, 2018

Study Completion

August 31, 2019

Last Updated

October 3, 2019

Record last verified: 2019-07

Locations

FR(1)