The primary objective is to study the relationship between these monitoring tools (TCD, EEG, ICP and CT perfusion) and the neurological outcome and to create a multimodal model for outcome prediction. The secondary objective is to study theā¦
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Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are:
- EEG measurements during the first seven days of ICU admission
- TCD measurements, performed twice a day during the first week
- ICP measurement (on indication)
- CT brain scan at admission
- CT brain perfusion scan at day 1 and day 7 (6-8)
The GOSE at 12 months (obtained by telephone), will be used as the primary
outcome parameter.
Secondary outcome
Secundary study parameters are:
- Basic trauma and clinical data, including: age, sex, injury characteristics,
initial GCS, GCS during ICU admission, pupillary abnormalities, pre-injury
morbidity, haemodynamics, use of vasopressors (cumulative dose), saturation and
glucose levels.
- CT and MRI data obtained for routine clinical practise
Secondary outcome parameters are:
- neurological outcome evaluated by the GOSE at hospital discharge and 6
months.
Background summary
Traumatic brain injury (TBI) is an important cause of death and disability
especially in young adults. Treatment of this heterogeneous patient group is
however challenging because of difficulties in monitoring real-time dynamics in
brain dysfunction which may lead to secondary brain damage. Achieving an
adequate cerebral bloodflow is of major importance in preventing such secondary
cerebral damage which is the cornerstone of treatment in TBI. Cerebral
perfusion computed tomography (CT perfusion) is a technique which makes it
possible to rapidly and easily evaluate cerebral perfusion in different brain
regions and therefore can identify brain areas which are prone to ischemia or
hypoperfusion. Rapid fluctuations in cerebral hemodynamics are however not
detected by imaging techniques such as computed tomography (CT) scans and
magnetic resonance imaging (MRI). Therefore bedside tools for the assessment of
cerebral perfusion are mandatory for on demand therapeutic interventions.
Transcranial doppler (TCD) measures direct cerebral blood flow velocity, is
non-invasive in nature, and can be performed semi-continuously.
Electroencephalographic (EEG) monitoring also detects rapid changes in the
function of regional cortical neurons and seems therefore promising in locating
cortical regions vulnerable for secondary brain damage. Intracranial pressure
(ICP) transducers give information about progressive intracerebral space
occupying lesions leading to intracranial hypertension subsequently
compromising cerebral blood flow.
Integrating the above mentioned tools and assessing their relations in terms of
cerebral perfusion may lead to a specific model which gives a more detailed
insight in the development and pathophysiological processes of secondary brain
damage following the initial TBI.
Study objective
The primary objective is to study the relationship between these monitoring
tools (TCD, EEG, ICP and CT perfusion) and the neurological outcome and to
create a multimodal model for outcome prediction. The secondary objective is to
study the functional relationships between the monitoring tools (TCD,
continuous EEG, ICP measurement and CT perfusion).
Ultimately, we aim to develop an integrated model that leads to better
recognition of pathophysiological changes after TBI and that can be used for
the detection of secondary brain damage in an early stage.
Study design
This is a prospective, observational, single centre, cohort study.
Study burden and risks
There is no associated risk for participating patients. Continuous EEG and TCD
are both non-invasive monitoring tools. The placement of an ICP transducer and
serial native CT-imaging are part of normal clinical practice, so applying the
study protocol does not introduce further risk to patients concerning these
interventions. The introduction in the study protocol of a non-ionized
iodinated contrast agent in cerebral perfusion computed tomography imaging of
the brain introduces a very small risk for anaphylactic reactions, 1 to 2 per
10.000 interventions. In patients with normal renal function there is no
associated risk for the development of contrast nephropathy. Patients with
known renal dysfunction, who have a higher risk for contrast enhanced
nephropathy, are excluded from the study protocol. Furthermore, the use of
contrast agents in imaging in trauma patients is part of normal clinical
practice. Follow-up will be performed by telephone at 6 and 12 months.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- Severe or moderate TBI (Glasgow Coma Scale of 3-12 measured at trauma site or the Emergency Department).
- Admission to the ICU.
- Age 18 years or older.
Exclusion criteria
- Patients after cardiopulmonary resuscitation with suspected postanoxic encephalopathy.
- Earlier hospitalization for TBI or stroke without full neurological recovery.
- Any progressive brain illness, such as a brain tumour or neurodegenerative disease.
- A limited life expectancy (<6 months).
- High risk for the development of iodine contrast induced nephropathy (according to local protocol).
- Women who are (potentially) childbearing.
- Contrast allergy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60512.044.17 |
Other | volgt |