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CompletedNCT03535428Updated Oct 3, 2019

Venous Thrombo-embolic Complication prévention in Pelvic Surgery

An observational study in Venous Thromboembolism and Pelvic Surgery, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Venous Thromboembolism
  • Pelvic Surgery
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In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 100 is below the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient with pelvic surgery indication consulting surgeons

Inclusion criteria

  • pelvic fracture with surgery indication
  • age above 18 years

Exclusion criteria

Exclusion Criteria:

  • pelvic fracture without surgery indication
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • VENOUS exploration

    Diagnostic Test: VENOUS exploration

Interventions

  • Diagnostic testVENOUS exploration

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

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What researchers measure

Primary outcomes

  1. major thrombo-embolic events

    Time frame: Day 10 after surgery

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03535428
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
May 24, 2018
Start date
Feb 13, 2017
Primary completion
Apr 25, 2018
Completion
Aug 31, 2019
Last update
Oct 3, 2019

Study contacts

BONHOMME Stéphanie, MD
principal investigator · GHPSJ
RIOUALLON Guillaume, MD
study director · GHPSJ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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