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Assessment of brain and eye blood flow after traumatic brain injury

Real-time assessment of retinal perfusion and blood flow as a surrogate measure for cerebral perfusion in severe traumatic brain injury

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN33668699
Enrollment
80
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute severe traumatic brain injury Injury, Occupational Diseases, Poisoning

Interventions

Patients will have cerebral and retinal perfusion assessed after TBI. Invasive neuromonitoring will assess cerebral oxygenation and intracranial pressure and collect cerebral microdialysis. Ocular ima

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactRichard Blanch
r.j.blanch@bham.ac.uk+44 (0)121 3712000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026