None listed
Conditions
Brief summary
The objective of this study, in adults with moderate to severe TBI, is to use machine learning and determine and compare the univariate and multivariate associations between neuroimaging biomarkers, blood biomarkers, clinical data and neurological outcomes. Specific aims are as follows: 1. To identify neuroimaging biomarkers of TBI, measured as structural and functional damage on brain MRI, on discharge from ICU/HDU (or if not admitted to ICU, once the participant is stable on the ward)and changes in structural damage and neuro-inflammation during recovery at 3- and 6-months after injury. 2. To determine the multivariate associations between neuroimaging biomarkers of TBI and neurological outcomes 3- and 6-months after injury, using a combination of deep learning and other machine learning methodologies. 3. To determine correlations between neuroimaging biomarkers, blood biomarkers (ccfDNA, exosomes, clinical data and neurological outcomes of TBI on discharge from ICU and at 3- and 6-months after injury. 4. To determine correlations between 3-month and 6-month changes in neuroimaging biomarkers, blood biomarkers, clinical data and neurological outcomes. 5. To determine the independent predictors of neurological outcomes at 3- and 6-months after injury using deep learning. 6. To assess aims 2-4 in the subgroup of patients who have MRI scans (during their ICU/HDU admission) as part of their clinical care
Interventions
Participants will undergo blood tests for specific biomarker analyses and Magnetic Resonance scans.
Blood samples (25ml) will be taken at the following times by a phlebotomy trained nurse or phlebotomist:
Within 36 hours of injury
Between 48 and 72 hours of injury
Day 4 post injury
Day 7 post injury
Day 14 post injury
3 month post injury (+/- 14 days)
MRI scans will be done up to 3 times by trained radiographers and/or technicians with medical cover always provided, at the following timepoints:
Participants will undergo blood tests for specific biomarker analyses and Magnetic Resonance scans. Blood samples (25ml) will be taken at the following times by a phlebotomy trained nurse or phlebotomist: Within 36 hours of injury Between 48 and 72 hours of injury Day 4 post injury Day 7 post injury Day 14 post injury 3 month post injury (+/- 14 days) MRI scans will be done up to 3 times by trained radiographers and/or technicians with medical cover always provided, at the following timepoints: Following discharge from ICU 3 months post injury (+/- 14 days) 6 months post injury (+/- 21 days) MRIs will take approximately one hour. All study procedures will cease six months post injury. Study outcome questionnaires will be administered 3 and 6 months post injury, either face to face or over the phone by a research coordinator. These questionnaires are PHQ-9, PHQ-15, BRS, BRISC, GAD-7, PROMIS, GOS-E, PCL-5
Sponsors
University of Queensland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years old 2. Diagnosed with moderate or severe TBI*, with or without other injuries. *TBI Definition - A TBI will be defined based on the post-resuscitation Glasgow Coma Scale (GCS) in the pre-hospital period and the first 24 hours of ICU admission, if admitted to ICU. Moderate and Severe TBI are defined by the following categories of GCS if in the opinion of the treating team GCS is not solely due to intoxication, sedation, or extracranial injury • Moderate TBI is defined as a GCS score of 9-12 • Severe TBI is defined as a GCS score of less than or equal to 8
Exclusion criteria
1. Previous major stroke 2. Pregnancy, or may be pregnant 3. In the opinion of the investigator the participant would be unlikely to be able to comply with study procedures and follow up (e.g. lives overseas). 4. Presence of underlying disease with a life expectancy of less than 6 months 5. Known contraindication to MRI that will prevent study procedures 6. Patients who have suffered a devastating TBI with either progression towards brain death at the time of assessment or where the treating medical team are not committed to ongoing full supportive care 7. Traumatic brain injury occurred more than 72 hours ago
Outcome results
None listed