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Severe Brain TraumaNCT01990963

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

An observational study of Severe Brain Trauma, run by Università degli Studi dell'Insubria at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Brain Trauma
How many people
60 participants
Where
1 siteItaly
Study dates
Jan 2010to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Male and female, any ethnic group with severe brain trauma

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda ospedaliera ospedale Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

About this study

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

Read the 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.
Keywords
Brain trauma;, MALUNA;, densitometric data, CT
Medical subject headings
Brain Injuries, Traumatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma

    Measured: Participants will be followed for 8 days

Secondary outcomes (4)

  1. The evaluation of consciousness.

    During the observation are evaluated:

    • Glasgow Coma Scale (GCS).

    Measured: Participants will be followed for 8 days

  2. 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).

    Measured: Participants will be followed for 8 days

  3. The evaluation of brain pressures

    During the observation are evaluating:

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

    Measured: Participants will be followed for 8 days

  4. The evaluation of cardiac monitoring.

    During the observation are evaluating:

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

    Measured: Participants will be followed for 8 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01990963
Sponsor's protocol ID
346
Status last verified
May 2017
First submitted
7 Nov 2013
Last updated
25 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Brain Trauma, run by Università degli Studi dell'Insubria at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01990963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.

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