The Multicenter Italian INCEPT (INfarto CErebrale Post-Traumatico) Study

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.

Conditions

• TBI (Traumatic Brain Injury)
• Stroke Acute

Interventions

OTHER

posttraumatic cerebral infarction

the difference between groups refers to the developing of cerebral infarction after traumatic brain injury

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza

  collaborator OTHER

• Fondazione Poliambulanza Istituto Ospedaliero

  collaborator OTHER

• A.O. Ospedale Papa Giovanni XXIII

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Università degli Studi di Brescia

  collaborator OTHER

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  lead OTHER

Principal Investigators

• Nicola Latronico, MD · University of Brescia and AO Spedali Civili di Brescia

• Nazzareno Fagoni, MD · AO Spedali Civili di Brescia

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• Italy

Study Locations