Traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
BRaINS-TBI has two components:
1. BRaINS-TBI Predict – a prospective observational cohort study.
2. BRaINS-TBI CT – a nested pragmatic randomised controlled trial evaluating the impact of using i-STAT
Sponsors
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: BRaINS-TBI Predict (Observational Cohort Study) Patients who have sustained a head injury: 1. = 16 years of age 2. Glasgow Coma Score 13, 14, or 15 3. Presentation within 24 hours of sustaining a head injury 4. Meet criteria to be assessed for consideration of a head CT using NICE NG232 clinical decision support tool (CDST). 5. Patients with a prior history of TBI which required clinical assessment but occurred more than 1 year prior may still be included. Non-head injury trauma patient controls: 6. = 16 years of age 7. Glasgow Coma Score 15 or at cognitive baseline 8. Presentation within 24 hours of trauma to part of body other than head. No head injury noted by patient and/or witnesses Healthy Volunteers: 9. Adult = 16 years of age BRaINS-TBI CT (Nested RCT): 1. = 18 years of age 2. Glasgow Coma Score 13, 14, or 15 3. Presentation within 24 hours of head injury 4. When assessed using NICE NG232 clinical decision support tool (CDST) found to have loss of consciousness or amnesia plus any of 4.1. Age 65 years or over 4.2. Any bleeding or clotting disorders (liver failure, haemophilia, taking anticoagulants or antiplatelets) 4.3. Dangerous mechanism of injury (a pedestrian or cyclist struck by a motor vehicle, an occupant ejected from a motor vehicle, or fall from a height of more than 1m or 5 stairs) 4.4. More than 30 minutes’ retrograde amnesia of events immediately before the head injury 4.5. Subjects on anticoagulant or antiplatelet agents, excluding aspirin monotherapy, with no other high or medium risk features and shared decision making positive for CT
Exclusion criteria
Exclusion criteria: BRaINS-TBI Predict (Observational Cohort Study) Patients who have sustained a head injury: 1. Participant without capacity and no available patient legal representative or professional consultee available. 2. Participant with capacity unwilling to provide informed consent 3. Unable to adequately understand written and verbal English for consent and assessments unless an appropriate translator is available. Non-head injury trauma patient controls: 4. Any evidence of a current head injury 5. History of a previous head injury requiring medical care. 6. Participant without capacity and no available patient legal representative or professional consultee. 7. Participant with capacity unwilling to provide informed consent 8. Unable to adequately understand written and verbal English for consent and assessments unless an appropriate translator is available. Healthy Volunteers: 9. Prior history of head injury/traumatic brain injury requiring medical assessment or care 10. Other significant neurological disease requiring ongoing treatment/management BRaINS-TBI CT (Nested RCT): 1. Low risk TBI according to NICE-CDR 2. Significant extra-cranial injury for which a full trauma CT would usually be indicated. 3. Any NICE Guideline (NG232) high risk criteria 3.1. GCS = 12 on initial assessment in the ED (aside from intoxicated subjects with no other concerning features) 3.2. Suspected open or depressed skull fracture 3.3. Any sign of basal skull fracture (haemotympanum, 'panda' eyes, cerebrospinal fluid leakage from the ear or nose, Battle's sign) 3.4. Post-traumatic seizure 3.5. Focal neurological deficit 3.6. More than 1 episode of vomiting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the observational cohort (BRaINS-TBI Predict): Extended Glasgow Outcome Scale (GOSE) at six months. For analysis GOSE will be dichotomised as GOSE<8 (GOSE 1-7 vs 8) which is often described as incomplete recovery versus complete recovery. For the randomised trial (BRaINS-TBI CT): Percentage of patients with computed tomography (CT) scans of the head (brain) ordered to rule out a clinically significant intracranial lesion during the Emergency Department visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the observational cohort (BRaINS-TBI Predict): Glasgow Outcome Score Extended (GOSE) at 6 months dichotomised into other commonly used categories (GOSE=6 (GOSE 2-6 vs 7-8), and GOSE=4 (GOSE 2-4 vs 5-8). Three-month GOSE, symptom type + burden from RPQ and PRS, quality of life, mental health and neurocognitive function. These other outcome measures will be used to assess for ceiling effects in GOSE as well as ensuring outcomes important to patients are assessed. Planned subgroup analyses: Sex, >65 years, major extracranial injury, renal dysfunction (eGFR) and significant co-morbidities (e.g. dementia, other neurological disease). Effect of timing of blood sampling (<6 hours, <12 hours, 12 to 24 hours) and effect of two blood samples. For the randomised trial (BRaINS-TBI CT): Deterioration up to 30 days after ED attendance. A planned composite outcome measure will be comprised of: death attributable to TBI within 30 days of first presentation, requirement for neurosurgical intervention, seizure, neurological deterioration (new deficit or drop in GCS of more than 2 points), intensive care unit (ICU) admission for TBI, intubation recorded within 30 days of first presentation, or hospital readmission for TBI within 30 days of first presentation. Where reason for death, ICU admission, or readmission is unknown, it will be attributed to TBI deterioration. To ensure that no signal of harm is missed each component will be assessed individually as well as the overall composite measure. | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactVirginia;Emma Newcombe;Flanagan
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Outcome results
None listed