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

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

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy, 21100
    • Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female, any ethnic group with severe brain trauma

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma	Participants will be followed for 8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of consciousness.	During the observation are evaluated: • Glasgow Coma Scale (GCS).	Participants will be followed for 8 days
The evaluation of clinical conditions.	During the observation are evaluated multiparametric arterial and venous gas analysis : partial pressure of oxygen in arterial blood(PaO2); partial pressure of carbon dioxide in the arterial blood (PaCO2); cerebral venous oxygen saturation (SjO2); arterial oxygen saturation (SaO2); measure of the acidity or basicity of an aqueous solution (pH); base excess (B.E.); bicarbonate ion (HCO3-); sodium ion (Na+); potassium ion (K+); glycemia; blood concentration of hemoglobin(Hb); hematocrit (Ht).	Participants will be followed for 8 days
The evaluation of brain pressures	During the observation are evaluating: • Intracranial Cerebral Pressure (ICP) if monitored and perfusional cerebral pressure(PCP);	Participants will be followed for 8 days
The evaluation of cardiac monitoring.	During the observation are evaluating: • Mean arterial pressure (MAP), cardiac frequency (FC), body temperature, water balance, diuresis;	Participants will be followed for 8 days

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Paolo MD Severgnini, Prof., Università degli Studi dell'Insubria, Varese, Italia

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 16, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: CT; Brain trauma;; MALUNA;; densitometric data
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 346