Venous Thrombo-embolic Complication prévention in Pelvic... | NCT03535428

Studies
Venous Thrombo-embolic Complication prévention in Pelvic Surgery

NCT03535428

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Oct 3, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Venous Thromboembolism
Pelvic Surgery

Interventions

VENOUS exploration

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2017Actual

Primary Completion Date

Apr 25, 2018Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

May 11, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

May 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2019

Last Update Posted Date

Oct 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VENOUS exploration			Diagnostic Test: VENOUS exploration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VENOUS exploration	Diagnostic Test	venous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery	VENOUS exploration

Measure	Description	Time Frame
major thrombo-embolic events		Day 10 after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pelvic fracture with surgery indication
age above 18 years

Exclusion Criteria:

pelvic fracture without surgery indication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient with pelvic surgery indication consulting surgeons

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
BONHOMME Stéphanie, MD	GHPSJ	Principal Investigator
RIOUALLON Guillaume, MD	GHPSJ	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D054556	Venous Thromboembolism

Ancestor Terms

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided