TBI (Traumatic Brain Injury) Clinical Trial
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
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.
n/a
Observational Model: Case Control, Time Perspective: Prospective
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