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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430324
• Other study ID #: prot.1937/2009
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: April 27, 2015
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Bioethics CommitteeItaly: National Institute of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Stroke Acute
• TBI (Traumatic Brain Injury)

Intervention

Other:
• posttraumatic cerebral infarction
the difference between groups refers to the developing of cerebral infarction after traumatic brain injury

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia

Sponsors (8)

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

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Ghajar J. Traumatic brain injury. Lancet. 2000 Sep 9;356(9233):923-9. Review. — View Citation

Lingsma HF, Roozenbeek B, Steyerberg EW, Murray GD, Maas AI. Early prognosis in traumatic brain injury: from prophecies to predictions. Lancet Neurol. 2010 May;9(5):543-54. doi: 10.1016/S1474-4422(10)70065-X. Review. — View Citation

Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9. Review. — View Citation

Marino R, Gasparotti R, Pinelli L, Manzoni D, Gritti P, Mardighian D, Latronico N. Posttraumatic cerebral infarction in patients with moderate or severe head trauma. Neurology. 2006 Oct 10;67(7):1165-71. — View Citation

Mirvis SE, Wolf AL, Numaguchi Y, Corradino G, Joslyn JN. Posttraumatic cerebral infarction diagnosed by CT: prevalence, origin, and outcome. AJNR Am J Neuroradiol. 1990 Mar-Apr;11(2):355-60. — View Citation

Rosenfeld JV, Maas AI, Bragge P, Morganti-Kossmann MC, Manley GT, Gruen RL. Early management of severe traumatic brain injury. Lancet. 2012 Sep 22;380(9847):1088-98. doi: 10.1016/S0140-6736(12)60864-2. Review. — View Citation

Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 May 29;370(22):2121-30. doi: 10.1056/NEJMra1208708. Review. — View Citation

Tawil I, Stein DM, Mirvis SE, Scalea TM. Posttraumatic cerebral infarction: incidence, outcome, and risk factors. J Trauma. 2008 Apr;64(4):849-53. doi: 10.1097/TA.0b013e318160c08a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Handicap Scale (OHS)	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	patients will be evaluated at hospital discharge, an expected average of 3 weeks	No
Primary	Glasgow Outcome Scale (GOS)	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	the GOS will be performed 6 months after the hospital admission	No
Secondary	Hospital and ICU mortality	This outcome refers to the mortality during ICU stay 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	No
Secondary	Length of ventilation	Days of ventilation, how long does it take to weaning from ventilation	during ICU stay, an expected average of 3 weeks	No
Secondary	Length of ICU and Hospital stay	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	at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks	No