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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Università degli Studi dell'Insubria
Sponsor:
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01990963
First received: November 7, 2013
Last updated: November 16, 2013
Last verified: November 2013
  Purpose

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


Condition
Severe Brain Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.

Resource links provided by NLM:


Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma [ Time Frame: Participants will be followed for 8 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The evaluation of consciousness. [ Time Frame: Participants will be followed for 8 days ] [ Designated as safety issue: Yes ]

    During the observation are evaluated:

    • Glasgow Coma Scale (GCS).


  • The evaluation of clinical conditions. [ Time Frame: Participants will be followed for 8 days ] [ Designated as safety issue: Yes ]

    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).


  • The evaluation of brain pressures [ Time Frame: Participants will be followed for 8 days ] [ Designated as safety issue: Yes ]

    During the observation are evaluating:

    • Intracranial Cerebral Pressure (ICP) if monitored and perfusional cerebral pressure(PCP);


  • The evaluation of cardiac monitoring. [ Time Frame: Participants will be followed for 8 days ] [ Designated as safety issue: Yes ]

    During the observation are evaluating:

    • Mean arterial pressure (MAP), cardiac frequency (FC), body temperature, water balance, diuresis;



Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Male and female, any ethnic group with severe brain trauma

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990963

Contacts
Contact: Paolo MD Severgnini, Prof. 0039.0332.278801 paolo.severgnini@uninsubria.it

Locations
Italy
Azienda ospedaliera ospedale Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Contact: Paolo MD Severgnini, Prof.    0039-0332-278801    paolo.severgnini@uninsubria.it   
Principal Investigator: Matteo MD Rovera, Dr.         
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Paolo MD Severgnini, Prof. Università degli Studi dell'Insubria, Varese, Italia
  More Information

No publications provided

Responsible Party: Paolo Severgnini, Prof., Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01990963     History of Changes
Other Study ID Numbers: 346
Study First Received: November 7, 2013
Last Updated: November 16, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Università degli Studi dell'Insubria:
Brain trauma;
MALUNA;
densitometric data
CT

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 22, 2014