An observational study in Traumatic Brain Injury, sponsored by Imperial College London. Completed at 5 sites in 4 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Imperial College London · Observational
Observational longitudinal study assessing outcomes following moderate-severe traumatic brain injury (TBI).
Traumatic brain injury (TBI) occurs when the brain is physically damaged, for example after a car crash. It is common and survivors often have major on-going problems. It is very difficult to predict how patients will do after TBI. One reason for this is that clinicians and researchers are unable to measure all the effects of TBI. An important factor is that the connections between nerve cells are damaged by the impact on the brain of an injury (axonal injury). This damage has been difficult to measure in the past, but new ways to scan the brain and more sensitive ways of picking up the effects of this injury in the blood could change this. In other parts of medicine tests of this type have had a dramatic effect on how clinicians treat patients. For example, the products of heart muscle damage that have leaked into the blood can be used identify a heart attack and guide treatment. Clinicians need similar tests to be available in TBI. This should be possible as the products of axonal injury also leak into the blood and researchers have a sensitive way to pick this up. An accurate test for axonal injury would guide treatment choices and allow clinicians to predict how patients will recover. The investigators have brought together an international team who have been working on different aspects of this problem for many years. Together the investigators will conduct a large study to identify the best measures of axonal injury. The investigators will carefully test whether these measures help predict outcomes and will study where the blood markers come from using a safe method to measure the effects of axonal injury directly from the brain. The work links into some large projects that have already started and will use a standard way to assess patients after their injury. This is important because it will allow researchers to share results across studies. The investigators hope the work will allow us to identify a blood marker for TBI that could be widely used to quickly identify the presence of axonal injury. The investigators will also show what brain imaging measure is best at picking up axonal injury and how best to combine the measures to best predict how patients recover. This will allow doctors to diagnose problems after TBI more accurately, choose the right treatments and give patients and their families accurate advice about what will happen after discharge from hospital.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 313 is above the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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250 traumatic brain injury patients from ITU / major trauma ward.
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Work package 1. In a large multi-centre cohort of adult moderate/severe TBI patients we aim to identify the most informative plasma biomarker(s) of the severity of axonal injury. We will characterise their time course, focusing on neurofilament light (NFL) and tau, and relate these to magnetic resonance imaging (MRI) measures of axonal injury. Using logistic regression we will then test whether these measures contribute to the prediction of clinical outcome at twelve months
Diagnostic Test: MRI · Diagnostic Test: Blood Sampling · Diagnostic Test: Neuropsychological tests
Work package 2. In a subgroup of the patients recruited to WP1 we will use advanced MRI and longitudinal assessments to provide a more detailed description of the relationship between the plasma biomarkers and outcome after TBI. We will test whether advanced diffusion and myelin integrity measures correlate with plasma biomarkers and whether early plasma biomarker levels predict neurodegeneration measured by progressive atrophy after TBI.
Diagnostic Test: MRI · Diagnostic Test: Blood Sampling · Diagnostic Test: Neuropsychological tests · Diagnostic Test: MRI (advanced)
Work package 3. In a second subgroup of patients recruited to WP1 we will combine microdialysis, neuroimaging and plasma sampling of axonal proteins to provide a deeper understanding of the mechanisms of axonal injury progression and use this approach to investigate the axonal origin of the plasma biomarkers.
Diagnostic Test: MRI · Diagnostic Test: Blood Sampling · Diagnostic Test: Microdialysis · Diagnostic Test: Neuropsychological tests · Diagnostic Test: MRI (advanced)
Single assessment using MRI, bloods and cognitive testing.
Diagnostic Test: MRI · Diagnostic Test: Blood Sampling · Diagnostic Test: Neuropsychological tests
Magnetic Resonance Imaging
Sampling of serum
Monitoring of cerebral fluid protein levels
Battery of tests to assess cognitive function, patient outcomes
Advanced MRI
Change in diffusion tensor imaging measures over time
Fractional anisotropy (FA)
Time frame: 10 days - 6 weeks, 6 months and 12 months
Brain atrophy rates
Brain tissue volume changes over time.
Time frame: 10 days - 6 weeks, 6 months and 12 months
Change in levels of fluid biomarkers in blood
Neurofilament light and Tau protein
Time frame: 0-5 days, 5-10 days, 10 days - 6 weeks, 6 months and 12 months
Change in levels of fluid biomarkers in cerebral fluid
Neurofilament light and Tau protein
Time frame: 48 hours to 7 days
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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