Venous ThromboembolismNCT03535428
Venous Thrombo-embolic Complication prévention in Pelvic Surgery
An observational study of Venous Thromboembolism and Pelvic Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Pelvic Surgery
- What is being tested?
- VENOUS exploration
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2017to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with pelvic surgery indication consulting surgeons
Who may be able to join
- pelvic fracture with surgery indication
- age above 18 years
Who cannot join
- pelvic fracture without surgery indication
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
- Conditions
- Venous Thromboembolism, Pelvic Surgery
- Being tested
- VENOUS exploration
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENOUS explorationDiagnostic test
venous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery
| Study group | Role | What they receive |
|---|---|---|
| VENOUS exploration | Not described Receives: Diagnostic Test: VENOUS exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
major thrombo-embolic events
Measured: Day 10 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start13 Feb 2017
- Primary completion25 Apr 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BONHOMME Stéphanie, MD, Principal investigator, GHPSJRIOUALLON Guillaume, MD, Study director, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535428
- Sponsor's protocol ID
- PREVENTION MTEVbassin
- Status last verified
- Jul 2019
- First submitted
- 11 May 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thrombo-embolic Complication prévention in Pelvic Surgery
- ClinicalTrials.gov ID
- NCT03535428
- Acronym / sponsor ID
- PREVENTION MTEVbassin
- Conditions
- Venous Thromboembolism, Pelvic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VENOUS exploration | – | Diagnostic Test: VENOUS exploration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with pelvic surgery indication consulting surgeons
Key inclusion criteria (2 listed)
- pelvic fracture with surgery indication
- age above 18 years
Key exclusion criteria (1 listed)
- pelvic fracture without surgery indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENOUS explorationvenous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery | Diagnostic test | VENOUS exploration |
Primary outcome
major thrombo-embolic events
Time frame: Day 10 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BONHOMME Stéphanie, MD principal investigator
GHPSJ
RIOUALLON Guillaume, MD study director
GHPSJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Pelvic Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major thrombo-embolic events (time frame: Day 10 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.