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

Severe Brain Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01990963
• Other study ID #: 346
• Status: Active, not recruiting
• Phase: N/A
• First received: November 7, 2013
• Last updated: May 23, 2017
• Start date: January 2010
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Severe Brain Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Italy	Azienda ospedaliera ospedale Circolo e Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma		Participants will be followed for 8 days
Secondary	The evaluation of consciousness.	During the observation are evaluated: • Glasgow Coma Scale (GCS).	Participants will be followed for 8 days
Secondary	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
Secondary	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
Secondary	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