TBI (Traumatic Brain Injury)NCT02430324
The Multicenter Italian INCEPT (INfarto CErebrale Post-Traumatico) Study
An observational study of TBI (Traumatic Brain Injury) and Stroke Acute, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury), Stroke Acute
- What is being tested?
- posttraumatic cerebral infarction
- How many people
- 143 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with moderate or severe brain injury, monitored with invasive intracranial pressure.
Who may be able to join
- 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
Who cannot join
- age <16 years old,
- mild head trauma,
- absence of invasive ICP or invasive arterial pressure monitoring,
- dying patients,
- absence of brain stem reflexes.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Brescia, 25123
About this study
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).
Read more
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.
- Conditions
- TBI (Traumatic Brain Injury), Stroke Acute
- Being tested
- posttraumatic cerebral infarction
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posttraumatic cerebral infarctionOther
the difference between groups refers to the developing of cerebral infarction after traumatic brain injury
| Study group | Role | What they receive |
|---|---|---|
| TBI, no cerebral infarction | patients with moderate or severe brain injury that do not develop posttraumatic cerebral infarction | |
| TBI, posttraumatic cerebral infarction | patients with moderate or severe brain injury that develops posttraumatic cerebral infarction Receives: Other: posttraumatic cerebral infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: patients will be evaluated at hospital discharge, an expected average of 3 weeks
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
Measured: the GOS will be performed 6 months after the hospital admission
Secondary outcomes (3)
Hospital and ICU mortality
This outcome refers to the mortality during ICU stay and hospital stay
Measured: at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks
Length of ventilation
Days of ventilation, how long does it take to weaning from ventilation
Measured: during ICU stay, an expected average of 3 weeks
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
Measured: at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Fondazione Poliambulanza Istituto Ospedaliero, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliera San Gerardo di Monza, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero, Universitaria Pisana, Università degli Studi di Brescia
- Responsible party
- Principal investigator, Dr. Nazzareno Fagoni, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Nicola Latronico, MD, Study chair, University of Brescia and AO Spedali Civili di BresciaNazzareno Fagoni, MD, Principal investigator, AO Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430324
- Sponsor's protocol ID
- prot.1937/2009
- Status last verified
- Apr 2015
- First submitted
- 16 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghajar J. Traumatic brain injury. Lancet. 2000 Sep 9;356(9233):923-9. doi: 10.1016/S0140-6736(00)02689-1.
PubMed 11036909Marino 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.
PubMed 17030747Maas 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.
PubMed 18635021Mirvis 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.
PubMed 2107719Tawil 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.
PubMed 18404047Rosenfeld 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.
PubMed 22998718Lingsma 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.
PubMed 20398861Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 May 29;370(22):2121-30. doi: 10.1056/NEJMra1208708. No abstract available.
PubMed 24869722Latronico 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.
PubMed 32014041
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02430324
- Acronym / sponsor ID
- prot.1937/2009
- Conditions
- TBI (Traumatic Brain Injury), Stroke Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Fondazione Poliambulanza Istituto Ospedaliero, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliera San Gerardo di Monza, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero, Universitaria Pisana, Università degli Studi di Brescia
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI, no cerebral infarction | – | –patients with moderate or severe brain injury that do not develop posttraumatic cerebral infarction |
| TBI, posttraumatic cerebral infarction | – | Other: posttraumatic cerebral infarctionpatients with moderate or severe brain injury that develops posttraumatic cerebral infarction |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with moderate or severe brain injury, monitored with invasive intracranial pressure.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- age <16 years old,
- mild head trauma,
- absence of invasive ICP or invasive arterial pressure monitoring,
- dying patients,
- absence of brain stem reflexes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posttraumatic cerebral infarctionthe difference between groups refers to the developing of cerebral infarction after traumatic brain injury | Other | TBI, posttraumatic cerebral infarction |
Primary outcome
Oxford Handicap Scale (OHS)
Time frame: 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)
Time frame: 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
3 secondary outcomes
Hospital and ICU mortality
Time frame: at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks
Length of ventilation
Time frame: during ICU stay, an expected average of 3 weeks
Length of ICU and Hospital stay
Time frame: at the discharge from ICU, an expected average of 3 weeks; and at the discharge from hospital, an expected average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Background: PubMed 11036909Ghajar J. Traumatic brain injury. Lancet. 2000 Sep 9;356(9233):923-9. doi: 10.1016/S0140-6736(00)02689-1.
- Background: PubMed 17030747Marino 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.
- Background: PubMed 18635021Maas 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.
- Background: PubMed 2107719Mirvis 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.
- Background: PubMed 18404047Tawil 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.
- Background: PubMed 22998718Rosenfeld 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.
- Background: PubMed 20398861Lingsma 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.
- Background: PubMed 24869722Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 May 29;370(22):2121-30. doi: 10.1056/NEJMra1208708. No abstract available.
- Derived from this study: PubMed 32014041Latronico 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Latronico, MD study chair
University of Brescia and AO Spedali Civili di Brescia
Nazzareno Fagoni, MD principal investigator
AO Spedali Civili di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury) and Stroke Acute, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Handicap Scale (OHS) (time frame: patients will be evaluated at hospital discharge, an expected average of 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430324, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.