All patients are treated by standard treatments according to patterns of severity and in the light of different variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows:
Surgical evacuation of hemorrhagic masses and brain contusion
Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Prevention of secondary complications of critical illness included: preventive treatment of venous thromboembolism (VTE) and seizures
Patient who undergo surgical treatment, will recieve also postoperative intensive care treatments including: position of the head high, lower values of end-tidal CO2, sedation with reduced metabolic consumption of O2, increase in plasma osmolarity by administration of mannitol in controlled doses or hypernatremia, therapeutic CSF drainage

Standard treatment plus specific treatment. The investigational agent, the co-ultraPEALut, is administered orally twice daily (every 12 h) for 180 days in association with the specific therapy (e.g., antiplatelet agents, anticoagulants, antiepileptic drugs) commonly administered to these patients and/or with drugs prescribed for comorbidities (i.e. diabetes, arterial hypertension).

Traumatic Brain Injury

Co-ultraPEALut is administered to moderate traumatic brain injured patients for 180 days

Co-ultraPEALut (Glialia)

Department of Neurosurgery, University of Messina

Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury

Impairment of cognitive abilities will be evaluated by the Mini Mental State Examination (MMSE) (Folstein et al., 1975) adjusted for educational level and age. This is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time that is within the scope of this research. The threshold value for normal performance is set to 24 points. The outcome measure will be represented by the absolute score and by the change between the score recorded after 180 days and the baseline value

Brief Neuropsychological Cognitive Examination (BNCE) (Ball et al., 2009). This consists in 10 subtests composed of easily administered tasks, none requiring more than minimal reading skills.Total score indicating overall severity of impairment (expressed in percentage), subtest scores, and two aggregate scores for the simple and complex subtests are provided as percentage of the maximum score. The outcome measure will be represented by the absolute score and by the difference between the score recorded after 180 days and the baseline value

Depression will be assessed by the Beck inventory depression scale.This is a 21-question multiple-choice (scored 0-3 each) self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Scores will be categorized as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression
Depression score will be assessed at 180 days (T180) after trauma

Independence in activities of daily living and self-care will be assessed by the Barthel Index. This is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. Each domain is scored in one-point increments with a full score of 20 indicating functional independence. Independence will be assessed at 180 days (T180) after trauma

Alfredo Conti

Associate Professor

University of Messina

Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of admission.

Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of recruitment.

Supratentorial Brain Tumor

Serum Sodium

Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors

To observe relationship between hyponatremia in supratentorial tumor patients and in-hospital mortality.

To observe relationship between hyponatremia in supratentorial tumor patients and duration of hospital stay.

To observe relationship between hyponatremia in supratentorial tumor patients and rate of admission in intensive care unit.

To observe relationship between hyponatremia in supratentorial tumor patients and incidence of neurological deficits.

To observe relationship between hyponatremia in supratentorial tumor patients and incidence of seizures.

Dhritiman Chakrabarti

Assistant Professor

National Institute of Mental Health and Neuro Sciences, India

Hyponatremia

Ringer Lactate

Plasmalyte

140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial

hypernatremia/seizures

Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury

Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors

Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children

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