Acute severe traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with acute TBI: 1. Moderate to severe TBI 2. Over 18 years of age 3. Planned invasive neuromonitoring or insertion of invasive neuromonitoring consistent with the study protocol within the prior 24 hours 4. At least one eye with optically clear media to allow retinal imaging Healthy control participants: 1. Over 18 years of age 2. Two eyes 3. Capacity to consent 4. Willing and able to follow the protocol 5. No prior history of moderate to severe TBI 6. No prior history of retinal or optic nerve degenerative disease 7. At least one eye with optically clear media to allow retinal imaging
Exclusion criteria
Exclusion criteria: 1. Under 18 years of age 2. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the correlation between retinal perfusion and invasive neuromonitoring data: 1. Retinal perfusion will be assessed by OCTA at the time invasive neuromonitors are inserted, 24, 48, 72 hours (if neuromonitoring remains in situ), and 28 days later. 2. Cerebral perfusion pressure will be calculated as the difference between mean arterial pressure and intracranial pressure at the time invasive neuromonitors are inserted, 24, 48, and 72 hours later, or until invasive monitors are removed. 3. Cerebral oxygenation will be measured by brain tissue oxygen tension at the time invasive neuromonitors are inserted, 24, 48, 72 hours later or until the monitors are removed. 4. Cerebral microdialysis lactate to pyruvate ratio will be measured at the time invasive neuromonitors are inserted, 24, 48, 72 hours later or until invasive neuromonitors are removed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Middle cerebral artery Doppler will measure mean velocity, peak velocity, end diastolic velocity, and pulsatility index at the time of neuromonitors insertion, 24, 48, 72 hours, and 28 days later 2. Near infrared spectroscopy will assess cerebral cortical perfusion (total haemoglobin, oxyhaemoglobin, and deoxyhaemoglobin) at the time invasive neuromonitors are inserted, 24, 48, 72 hours, and 28 days later 3. 28-day mortality 4. 28-day neurological outcome assessed by the disability rating scale 5. The amplitude of retinal venous pulsation will be measured on video fundoscopy at the time invasive neuromonitors are inserted, 24, 48, 72 hours, and 28 days later 6. Microdialysate, CSF, and blood AQP4 expression will be assessed at the time invasive neuromonitors are inserted, 24, 48, 72 hours, or until the removal of invasive neuromonitors; primarily by ELISA 7. Total retinal, ganglion cell layer, and retinal nerve fibre layer thickness in the macula and peripapillary retina will be assessed with OCT at the time of neuromonitor insertion, 24, 48, 72 hours, and 28 days later 8. Intracranial pressure will be assessed by an invasive ICP monitor at the time of neuromonitor insertion, 24, 48, 72 hours later or until invasive neuromonitoring removal | — |
Countries
England, United Kingdom