Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02430324
Enrollment
143
Registered
2015-04-30
Start date
2009-12-31
Completion date
2012-12-31
Last updated
2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Acute, TBI (Traumatic Brain Injury)

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.

Interventions

OTHERposttraumatic cerebral infarction

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

Sponsors

A.O.U. Città della Salute e della Scienza
CollaboratorOTHER
Fondazione Poliambulanza Istituto Ospedaliero
CollaboratorOTHER
A.O. Ospedale Papa Giovanni XXIII
CollaboratorOTHER
Azienda Ospedaliera San Gerardo di Monza
CollaboratorOTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
Azienda Ospedaliero, Universitaria Pisana
CollaboratorOTHER
Università degli Studi di Brescia
CollaboratorOTHER
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxford Handicap Scale (OHS)patients will be evaluated at hospital discharge, an expected average of 3 weeksThe 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
Glasgow Outcome Scale (GOS)the GOS will be performed 6 months after the hospital admissionThe 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

MeasureTime frameDescription
Hospital and ICU mortalityat the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeksThis outcome refers to the mortality during ICU stay and hospital stay
Length of ventilationduring ICU stay, an expected average of 3 weeksDays of ventilation, how long does it take to weaning from ventilation
Length of ICU and Hospital stayat the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeksHow many days the patients whith cerebral infarction and without cerebral infarction have been in ICU, and how many days the patients were in hospital

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026