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NCT03535428 Clinical Trial

Venous Thrombo-embolic Complication prévention in Pelvic Surgery

Venous Thromboembolism Clinical Trial

Official title:
Venous Thrombo-embolic Complication prévention in Pelvic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03535428
Other study ID # PREVENTION MTEVbassin
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 13, 2017
Est. completion date August 31, 2019

Study information
Verified date July 2019
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 . 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 31, 2019
Est. primary completion date April 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pelvic fracture with surgery indication

- age above 18 years

Exclusion Criteria:

- pelvic fracture without surgery indication

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• VENOUS exploration
venous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery

Locations
Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary major thrombo-embolic events Day 10 after surgery
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