The Multicenter Italian INCEPT (INfarto CErebrale Post-Traumatico) Study
NCT ID: NCT02430324
Last Updated: 2015-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
143 participants
OBSERVATIONAL
2009-12-31
2012-12-31
Brief Summary
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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
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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TBI, no cerebral infarction
patients with moderate or severe brain injury that do not develop posttraumatic cerebral infarction
No interventions assigned to this group
TBI, posttraumatic cerebral infarction
patients with moderate or severe brain injury that develops posttraumatic cerebral infarction
posttraumatic cerebral infarction
the difference between groups refers to the developing of cerebral infarction after traumatic brain injury
Interventions
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posttraumatic cerebral infarction
the difference between groups refers to the developing of cerebral infarction after traumatic brain injury
Eligibility Criteria
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Inclusion Criteria
* 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
* mild head trauma,
* absence of invasive ICP or invasive arterial pressure monitoring,
* dying patients,
* absence of brain stem reflexes.
16 Years
ALL
No
Sponsors
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A.O.U. Città della Salute e della Scienza
OTHER
Fondazione Poliambulanza Istituto Ospedaliero
OTHER
A.O. Ospedale Papa Giovanni XXIII
OTHER
Azienda Ospedaliera San Gerardo di Monza
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Azienda Ospedaliero, Universitaria Pisana
OTHER
Università degli Studi di Brescia
OTHER
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Responsible Party
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Dr. Nazzareno Fagoni
Nazzareno Fagoni, MD
Principal Investigators
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Nicola Latronico, MD
Role: STUDY_CHAIR
University of Brescia and AO Spedali Civili di Brescia
Nazzareno Fagoni, MD
Role: PRINCIPAL_INVESTIGATOR
AO Spedali Civili di Brescia
Locations
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Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Brescia, Italy
Countries
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References
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Ghajar J. Traumatic brain injury. Lancet. 2000 Sep 9;356(9233):923-9. doi: 10.1016/S0140-6736(00)02689-1.
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. doi: 10.1212/01.wnl.0000238081.35281.b5.
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.
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.
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.
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.
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.
Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 May 29;370(22):2121-30. doi: 10.1056/NEJMra1208708. No abstract available.
Latronico N, Piva S, Fagoni N, Pinelli L, Frigerio M, Tintori D, Berardino M, Bottazzi A, Carnevale L, Casalicchio T, Castioni CA, Cavallo S, Cerasti D, Citerio G, Fontanella M, Galiberti S, Girardini A, Gritti P, Manara O, Maremmani P, Mazzani R, Natalini G, Patassini M, Perna ME, Pesaresi I, Radolovich DK, Saini M, Stefini R, Minelli C, Gasparotti R, Rasulo FA. Impact of a posttraumatic cerebral infarction on outcome in patients with TBI: the Italian multicenter cohort INCEPT study. Crit Care. 2020 Feb 3;24(1):33. doi: 10.1186/s13054-020-2746-5.
Other Identifiers
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prot.1937/2009
Identifier Type: -
Identifier Source: org_study_id