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Trial record 1 of 1 for:    NCT02430324
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The Multicenter Italian INCEPT (INfarto CErebrale Post-Traumatico) Study

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ClinicalTrials.gov Identifier: NCT02430324
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborators:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Fondazione Poliambulanza Istituto Ospedaliero
A.O. Ospedale Papa Giovanni XXIII
Azienda Ospedaliera San Gerardo di Monza
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Ospedaliero, Universitaria Pisana
Università degli Studi di Brescia
Information provided by (Responsible Party):
Dr. Nazzareno Fagoni, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:

Traumatic brain injury (TBI) is a leading cause of death and disability worldwide (Ghajar, 2000). With an estimated annual incidence of up to 500 per 100,000 population and more than 200 hospital admissions per 100,000 admissions in Europe each year, TBI is a major challenge to public health (Lingsma, 2010). Mortality and morbidity after TBI depend on several factors, either associated with patients characteristics, the cause of TBI, the neurological and general severity and secondary brain insults, the structural brain alterations as diagnosed at brain computed tomography (CT) (Rosenfeld, 2012).

The prognostic value of brain CT characteristics is well documented, including the status of basal cisterns, midline shift, the presence and type of intracranial lesions, and traumatic subarachnoid hemorrhage (Maas, 2008). Postraumatic cerebral ischemia, which includes functionally impaired yet still viable tissue, so-called ischemic penumbra, and irreversible cerebral infarction (PTCI), is frequent in patients who die after moderate or severe head trauma (Stocchetti, 2014).

Evidence of antemortem occurrence of PTCI is limited to three single-center retrospective studies, reporting a varying prevalence of 1.9%, 8% and 19.1% (Mirvis, 1990; Marino, 2006; Tawil, 2008). Increased intracranial pressure (ICP), blunt cerebral vascular injury, need for craniotomy and treatment with recombinant activated factor VII, have been demonstrated to be risk factors for PTCI. In one study, PTCI was an independent risk factor for poor outcome after moderate or severe head trauma with a two-fold increase in mortality and severe disability (Marino, 2006).

PTCI can be an important diagnosis in patients with significant TBI for various reasons. First, it might influence long-term outcome. Second, as an outcome that is measurable, and relevant to survival and lifestyle, PTCI could be used as an outcome measure in randomized controlled trials. Third, diagnosis of PTCI could be used as a standard diagnostic reference to validate early surrogate indicators of cerebral ischemia.

The investigators therefore planned a multi-center prospective study to investigate the impact of PTCI on disability at hospital discharge, and on 6-month morbidity and mortality in a population of moderate and severe adult TBI patients. The investigators also evaluated the role of intracranial hypertension, decreased cerebral perfusion pressure, hypotension and other secondary ischemic insults in determining the appearance of PTCI.


Condition or disease Intervention/treatment
TBI (Traumatic Brain Injury) Stroke Acute Other: posttraumatic cerebral infarction

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Study Type : Observational
Actual Enrollment : 143 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Post Traumatic Cerebral Infarction Increases Mortality and Morbidity in Patients With Moderate or Severe Head Trauma. The Multicenter Italian INCEPT (INfarto CErebrale Post-Traumatico) Study
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Group/Cohort Intervention/treatment
TBI, no cerebral infarction
patients with moderate or severe brain injury that do not develop posttraumatic cerebral infarction
TBI, posttraumatic cerebral infarction
patients with moderate or severe brain injury that develops posttraumatic cerebral infarction
Other: posttraumatic cerebral infarction
the difference between groups refers to the developing of cerebral infarction after traumatic brain injury




Primary Outcome Measures :
  1. Oxford Handicap Scale (OHS) [ Time Frame: patients will be evaluated at hospital discharge, an expected average of 3 weeks ]

    The Oxford Handicap Scale evaluates the outcome as follow: 0 no symptoms, 1 minor symptoms, 2 minor handicap, 3 moderate handicap, 4 severe handicap, 5 death.

    Favourable outcome: 0-3; unfavourable outcome: 4-5


  2. Glasgow Outcome Scale (GOS) [ Time Frame: the GOS will be performed 6 months after the hospital admission ]

    The Glasgow Outcome Scale evaluates the outcome as follow: 1 death, 2 vegetative state, 3 severe handicap, 4 moderate handicap, 5 good recovery.

    Favourable outcome: 4-5; unfavourable outcome: 1-3



Secondary Outcome Measures :
  1. Hospital and ICU mortality [ Time Frame: at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks ]
    This outcome refers to the mortality during ICU stay and hospital stay

  2. Length of ventilation [ Time Frame: during ICU stay, an expected average of 3 weeks ]
    Days of ventilation, how long does it take to weaning from ventilation

  3. Length of ICU and Hospital stay [ Time Frame: at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks ]
    How many days the patients whith cerebral infarction and without cerebral infarction have been in ICU, and how many days the patients were in hospital



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with moderate or severe brain injury, monitored with invasive intracranial pressure.
Criteria

Inclusion Criteria:

  • age >15 years old,
  • with moderate or severe head trauma (GCS <14),
  • admitted to ICU. Cases were classified as severe head injury (GCS score < 9), or moderate head injury (GCS score from 9 to 13).

All patients recruited were monitored by means of invasive intracranial pressure (ICP), invasive arterial pressure monitoring, peripheral oxygen saturation, in accordance with published international and local guidelines

Exclusion Criteria:

  • age <16 years old,
  • mild head trauma,
  • absence of invasive ICP or invasive arterial pressure monitoring,
  • dying patients,
  • absence of brain stem reflexes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430324


Locations
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Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Fondazione Poliambulanza Istituto Ospedaliero
A.O. Ospedale Papa Giovanni XXIII
Azienda Ospedaliera San Gerardo di Monza
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Ospedaliero, Universitaria Pisana
Università degli Studi di Brescia
Investigators
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Study Chair: Nicola Latronico, MD University of Brescia and AO Spedali Civili di Brescia
Principal Investigator: Nazzareno Fagoni, MD AO Spedali Civili di Brescia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Nazzareno Fagoni, Nazzareno Fagoni, MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT02430324    
Other Study ID Numbers: prot.1937/2009
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries