Main objective is to find clinical, genetic, biochemical and immunological markers of primary and secondary traumatic brain injury with the highest precision in predicting outcome after severe traumatic brain injury. Secondary objective is to gain…
ID
Source
Brief title
Condition
- Other condition
- Increased intracranial pressure and hydrocephalus
Synonym
Health condition
Trauma
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoints are genetic factors, clinical, biochemical and
inflammatory markers.
All parameters will be correlated to
- determinants of primary injury (GCS at presentation, CT-findings)
- determinants of secondary injury (hemodynamic, clinical and neurological
parameters after admission to ICU)
- MRI findings at 3 weeks and 6 months
- Outcome (as determined by the extended Glasgow Outcome Score at 6 and 12
months post injury)
- Neuropsychological testing at 3 weeks, 6 and 12 months post injury
- Parasympathetic activity (measured using heart rate variability)
Secondary outcome
Secondary objective of this study is to gain more insight in the
pathophysiological mechanisms underlying the primary impact and subsequent
ongoing cascade of events associated with secondary brain injury and
development of edema. Special attention will be given to biochemical markers of
brain injury and to inflammatory and vasogenic proteins and the possible
modulating role of increased vagal activity in these patients.
Background summary
Severe traumatic brain injury is a devastating disease with 30% mortality and
40 % chronic disability. Outcome is determined by both the primary insult and
secondary insults that thereafter. Prediction of outcome based on current
methods (CT and MRI) is expensive, laborious, not consistently reliable and not
universally available.
Study objective
Main objective is to find clinical, genetic, biochemical and immunological
markers of primary and secondary traumatic brain injury with the highest
precision in predicting outcome after severe traumatic brain injury. Secondary
objective is to gain more insight in the pathophysiology of secondary brain
injury and the development of brain oedema.
Study design
This is an interdisciplinary collaborative observational cohort study in
patients with severe traumatic brain injury
Study burden and risks
The burden and risks associated with participation to this study are minimal.
The total amount of blood samples is 640 ml in 10 days. Cerebrospinal fluid
will only be collected if a drain is present and holds no risk for the patient.
Most tests (including physical examination, Ct and MRI) are part of routine
medical care of these critically ill patients. The MRI at 3 weeks and the
neuropsychological testing is considered part of the protocol. This is a
non-therapeutic study carried out in incapacitated patients. Since it involves
patients after severe traumatic brain injury the subjects are incapacitated by
definition.
POstbus 9101
6500 HB Nijmegen
NL
POstbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Age >= 18
Severe TBI (GCS at first presentation <= 8)
Expected survival > 24 hours
Exclusion criteria
Pregnancy
No informed consent
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 | NL18306.091.07 |