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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03679416
Other study ID # 35RC17-3082_Cinescan
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 31, 2017

Study information

Verified date September 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 :

- Study of clinically unsuspected injuries discovered on WBCT

- Description

- Predictive factors

- Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Consecutives patients consulting the emergency department between August 1st 2016 and July 31th 2017 :

- Older than 18 y.o.

- WBCT performed,

- Victim of a high velocity RTC as defined by the presence of at least one criteria of the kinetics elements of the Vittel Criteria

- Normal physical exam of the chest, abdomen and pelvis,

- GCS score of 15

Exclusion Criteria:

- Opposition of the patient to the use of their CT-scan for research

- Patients who are under legal protection

- Patients who are incarcerated

Study Design


Related Conditions & MeSH terms

  • High Velocity Transport Accidents

Locations

Country Name City State
France Centre Hospitalier Universitaire de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of injuries diagnosed by Whole Body Computed Tomography (WBCT) that were not clinically suspected. Number of injuries diagnosed by WBCT that were not clinically suspected.
Classification in 3 categories according to their management :
Potentially severe, that involve modification of patients management
Injuries that could require further investigation according to the symptoms
Minor injuries that require no further investigation or specific management
The day of inclusion