Clinical trial NCT01990963: Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.
Official title: Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Brain Trauma
Keywords: Brain trauma;
MALUNA;
densitometric data
CT
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female, any ethnic group with severe brain trauma

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma
timeFrame: Participants will be followed for 8 days
Secondary outcomes:
measure: The evaluation of consciousness.
timeFrame: Participants will be followed for 8 days
measure: The evaluation of clinical conditions.
timeFrame: Participants will be followed for 8 days
measure: The evaluation of brain pressures
timeFrame: Participants will be followed for 8 days
measure: The evaluation of cardiac monitoring.
timeFrame: Participants will be followed for 8 days
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Study officials:
affiliation: Università degli Studi dell'Insubria, Varese, Italia
name: Paolo MD Severgnini, Prof.
role: PRINCIPAL_INVESTIGATOR
References: