Project A- To find biomarkers of traumatic brain damage and to find specific biomarkers of traumatic axonal injury.Project BTo investigate the value of MRI (T1, T2*, FLAIR, SWI and DTI) in detecting traumatic axonal lesions and predicting outcome.…
ID
Source
Brief title
Condition
- Other condition
- Seizures (incl subtypes)
Synonym
Health condition
traumatologische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Project A
Blood and (if possible) CSF/micro dialysis perfusate will be collected four
times a day during ICU/MCU admission to analyze the presence of primary and
secondary biochemical injury markers. A CT/MRI made within 72 hours after
injury will be used to assess primary focal or axonal damage. ICU registration
such as hypoxia, hypotension and increased ICP are used as indications for
secondary damage. The GOSE serves as the primary outcome measure.
Project B
A MRI-scan using T1, FLAIR, T2*, SWI and DTI will be performed within 3 weeks
and 6 months post-injury to assess diffuse axonal lesions and focal damage. An
extensive follow-up including cognitive, motor and neurological assessments at
4 weeks, 3,6 and 12 months post injury, is aimed at measuring the degree of
recovery. Furthermore, a broad neuropsychological evaluation and a structural
interview will be performed to evaluate behavioral/cognitive outcome at 6
months after injury.
Project C
For the genetics study, a blood sample will be collected at the Emergency
Department. The GOSE will be used as outcome measure.
Secondary outcome
not applicable
Background summary
Brain damage after head injury can be divided into primary or secondary injury
and into focal damage or diffuse axonal injury (DAI). DAI is an important
pathology after moderate/severe Traumatic Brain Injury (TBI) occurring in
approximately 40-50% of patients and is associated with poor outcome. Due to
its* microscopic nature, DAI is difficult to detect with commonly used imaging
techniques such as CT. Both biochemical markers and MRI are promising tools for
recognition and quantification of DAI and in this study we aim to investigate
their predictive value for outcome after TBI. Furthermore, the development of
DAI in relationship with cognitive and motor recovery and possible mediating
effects of genetic polymorphisms will be explored.
Study objective
Project A
- To find biomarkers of traumatic brain damage and to find specific biomarkers
of traumatic axonal injury.
Project B
To investigate the value of MRI (T1, T2*, FLAIR, SWI and DTI) in detecting
traumatic axonal lesions and predicting outcome.
Project C
To evaluate whether polymorphisms mediate responses to environmental impact to
the head and account for (a proportion of) the variability of intracranial
responses upon injury.
Study design
A prospective long-term follow-up cohort study
Study burden and risks
The study only includes non-invasive procedures and risk for the patient is
minimal. If participating in all elements of the study, a considerable time
investment is expected from participants. The investigators will therefore try
to integrate the data collection into the standard clinical care as much as
possible.
postbus 9101
6500 HB Nijmegen
Nederland
postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients who visit the emergency department with a moderate or severe TBI
2. Initial trauma occurred less than 24 hours before visiting the Emergency Department.
3. Age >= 18 years and <= 65 years
Exclusion criteria
Penetrating injury to the skull
No written informed consent by patient or proxy
History of severe neurological disease
Chronic alcohol or drug abuse
for MRI:
Metal implants other than teeth fillings
Claustrophobia
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 | NL18113.091.07 |