None listed
Conditions
Brief summary
This study looks at two proteins in the blood — GFAP and UCH-L1 — that are released when the brain is injured. We will measure these proteins in trauma patients admitted to intensive care, using two blood samples (one on admission and one 24 hours after injury), and compare the levels between patients with and without a traumatic brain injury. We will then see how well these blood markers predict patients' recovery six months later and compare our results against international standards to check whether the tests are reliable enough for everyday hospital use. We hypothesise that higher blood levels of GFAP and UCH-L1 are associated with the presence of traumatic brain injury and with poorer recovery at six months.
Interventions
a) Overview of information collected
The following data are collected for each participant, drawn from hospital records, ICU registry data (ANZICS/APACHE), and (where applicable) the linked EPO-TRAUMA and PRECISION-TBI datasets:
Demographic and injury data: gender, age, date and time of injury, mechanism of injury, Injury Severity Score (ISS), admission GCS and pupillary score (post-resuscitation), IMPACT-TBI score, history of pre-hospital hypotension/hypoxia, and highest educational level achi
a) Overview of information collected The following data are collected for each participant, drawn from hospital records, ICU registry data (ANZICS/APACHE), and (where applicable) the linked EPO-TRAUMA and PRECISION-TBI datasets: Demographic and injury data: gender, age, date and time of injury, mechanism of injury, Injury Severity Score (ISS), admission GCS and pupillary score (post-resuscitation), IMPACT-TBI score, history of pre-hospital hypotension/hypoxia, and highest educational level achieved. Biomarker data: plasma GFAP and UCH-L1 levels from two blood samples (ICU admission and 24 hours post-injury). Radiological data: CT brain reports (and MRI where performed) confirming presence/absence and predominant type of TBI, plus de-identified CT/MRI image files. Outcome data: ICU and hospital outcome data and 6-month functional outcomes — Glasgow Outcome Scale–Extended (GOS-E) for all relevant patients and additionally WHO-DAS and EQ-5D-5L for EPO-TRAUMA-linked patients. b) What is involved for participants Participant burden is minimal. The study is observational and pragmatic: blood sampling is timed to coincide with routine ICU arterial-line sampling, so little (=10 ml) or no additional blood is drawn beyond routine clinical care. No imaging or other tests are ordered solely for the study. Most data are obtained directly from medical records, registry datasets, and linked trial datasets. The only active participant involvement is a 6-month follow-up telephone interview (with the participant and/or their research decision-maker) to collect functional outcome measures — and for participants already enrolled in EPO-TRAUMA or PRECISION-TBI, even this is obtained via data-sharing agreements rather than a separate contact. c) Duration of observation Each participant is observed for 6 months following their traumatic injury — from ICU admission (with biomarker sampling at admission and 24 hours post-injury) through to the 6-month outcome assessment. (A subset of stored blood samples is additionally re-analysed at =1 year and =2.5 years post-collection to assess long-term sample stability.)
Sponsors
East Metropolitan Health Service
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients admitted to the ICU who: 1. Are less than 24 hours since suffering from a traumatic brain injury 2. Are expected to stay in the ICU for more than 48 hours 3. Are between 18 and 80 years old 4. Have CT brain imaging evidence of presence of traumatic brain injury
Exclusion criteria
Conditions which will cause a rise or alterations in GFAP and UCH-L1 levels independent of the TBI: 1. Spinal Cord Injury (radiological evidence) 2. A known central nervous system (CNS) and/or paraneoplastic malignancy. 3. Acute Kidney Injury (Creatinine levels greater than 1.5x baseline) or End-stage renal failure (receives chronic dialysis) 4. Pre-existing neurodegenerative disease (Parkinson’s, Alzheimer’s, Lewy body, etc.) 5. Cardiac arrest / suspected hypoxic-ischaemic encephalopathy. 6. Pregnancy/lactation/=3 months postpartum 7. Massive transfusion in the previous 12 hours Conditions that may interefere with the ability to assess outcomes: 1. Severe pre-existing physical or mental disability or severe comorbidity that may interfere with the assessment of outcome.
Outcome results
None listed