Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.

NCT ID: NCT01990963

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-05-31

Brief Summary

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Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of brain tissue after patients with severe brain trauma

Detailed Description

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Quantitative analysis of brain and structures in it, in terms of volume, weight and density, in patients with severe brain trauma, using MALUNA dedicated software to process DICOM images.

1. st endpoint: compare these data with those obtained by CT scans analysis of patients that recur to this kind of diagnostic investigation for non-traumatic events and with negative diagnostic related to cerebral pathological implication.
2. nd endpoint: relate data obtained with clinical evaluation of the patient (cerebral physiology and outcome)
3. rd endpoint: evaluate differences in terms of volume, weight and density of brain and its structures, between patients with diffuse cerebral injury and those with localized lesions.

Conditions

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Severe Brain Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male and female, any ethnic group
* Patient with severe brain trauma (GCS \< 8)
* Need of mechanical ventilation
* Clinical need of urgent CT study of brain.
* Need of clinical control of CT study of brain within first 72 hours from event
* Informed consent obtained from solicitor, due to the fact that patient is

Exclusion Criteria

* Age minor than 18 yrs old at hospitalization day
* Cardiac arrest pre-hospital or in-hospital and post-anoxic coma
* Non traumatic coma
* Exaggerated ingestion of depressors of central nervous system
* Documented abuse of narcotic drugs;
* Documented abuse of alcohol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Paolo Severgnini

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo MD Severgnini, Prof.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria, Varese, Italia

Locations

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Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Varese, , Italy

Site Status

Countries

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Italy

Other Identifiers

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346

Identifier Type: -

Identifier Source: org_study_id

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