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

U

Università degli Studi dell'Insubria

Status

Unknown

Conditions

Severe Brain Trauma

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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