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

Completed

• Conditions: Stroke Acute; TBI (Traumatic Brain Injury)
• Interventions: Other: posttraumatic cerebral infarction

• Registration Number: NCT02430324
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-04
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Study First Posted: 2015-04-30
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TBI, posttraumatic cerebral infarction	posttraumatic cerebral infarction	patients with moderate or severe brain injury that develops posttraumatic cerebral infarction

Primary Outcome Measures

Name	Time	Method
Oxford Handicap Scale (OHS)	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
Glasgow Outcome Scale (GOS)	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

Name	Time	Method
Hospital and ICU mortality	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
Length of ventilation	during ICU stay, an expected average of 3 weeks	Days of ventilation, how long does it take to weaning from ventilation
Length of ICU and Hospital stay	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

Trial Locations

Locations (1)

Azienda Ospedaliera Spedali Civili di Brescia; 🇮🇹 Brescia, Italy