An observational study in Traumatic Brain Injury, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Assiut University · Observational
This observational study aims to evaluate the combined use of transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound for early risk stratification of adults with traumatic brain injury (TBI) presenting to the Emergency Department. The study will assess whether ONSD measurements and TCD-derived middle cerebral artery pulsatility index (MCA-PI), in addition to clinical and computed tomography findings, can help identify patients at increased risk of early neurological deterioration. Adult patients with acute TBI and a Glasgow Coma Scale (GCS) score of 13 or less will be enrolled. TCD and ONSD measurements will be performed at emergency department presentation, with repeat measurements at 24 hours when clinically feasible in patients who have not developed early neurological deterioration. The primary outcome is early neurological deterioration within 24 hours.
Traumatic brain injury (TBI) is a major cause of morbidity and mortality and may be complicated by secondary neurological deterioration after the initial injury. Early identification of patients at increased risk of deterioration may facilitate closer monitoring and timely escalation of neurological management.
This prospective observational cohort study will be conducted in the Emergency Department of Assiut University Hospitals. Adult patients aged 18 years or older presenting with acute traumatic brain injury, a baseline Glasgow Coma Scale (GCS) score of 13 or less, and an initial computed tomography (CT) scan demonstrating a traumatic intracranial structural lesion will be considered for inclusion. Patients with an immediate neurosurgical indication, significant orbital trauma or ocular pathology interfering with reliable ONSD measurement, previous decompressive craniectomy, or an inadequate temporal acoustic window preventing reliable MCA-TCD assessment will be excluded.
At baseline, demographic and clinical data, neurological examination findings, GCS, pupillary findings, and CT findings will be recorded. CT severity will be assessed using the Rotterdam CT score. Bilateral optic nerve sheath diameter (ONSD) measurements and transcranial Doppler (TCD) assessment of the middle cerebral arteries will be performed at baseline. MCA pulsatility index (PI) will be the prespecified primary TCD variable for the primary predictive analysis, while other TCD parameters will be recorded as secondary or exploratory variables.
Patients will be followed for 24 hours for the primary outcome of early neurological deterioration (END), defined as a new or worsening neurological abnormality attributable to TBI, including a decrease in GCS of 2 or more points from baseline when clinically assessable, a new pupillary abnormality, or a new focal neurological deficit not present at baseline.
A repeat ONSD and TCD assessment will be performed at 24 hours only in patients who have not developed END before the scheduled assessment and when clinically feasible and safe. If END occurs before 24 hours, the exact time and type of deterioration will be recorded and research ultrasound examinations will be discontinued for that patient. No event-triggered research ultrasound examination will be performed.
Secondary outcomes will include radiological progression on repeat CT within 24 hours when clinically indicated as part of standard care, escalation of neurological management including emergency neurosurgical intervention, external ventricular drainage or other intracranial pressure-directed intervention, and in-hospital mortality. The study procedures will not delay or interfere with standard clinical management.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 60 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
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Adult patients presenting to the Emergency Department with acute traumatic brain injury, a baseline GCS score ≤13, and an initial CT brain scan demonstrating a traumatic intracranial structural lesion, who meet the predefined eligibility criteria and are initially managed conservatively/non-operatively.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients presenting to the Emergency Department with acute traumatic brain injury who meet the predefined eligibility criteria and undergo baseline transcranial Doppler and optic nerve sheath diameter assessment for early risk stratification and subsequent assessment of neurological outcomes.
Diagnostic Test: Transcranial Doppler and Optic Nerve Sheath Diameter Assessment
Transcranial Doppler ultrasonography and optic nerve sheath diameter measurement will be performed in eligible patients with traumatic brain injury presenting to the Emergency Department. Baseline measurements will include bilateral optic nerve sheath diameter and middle cerebral artery Doppler parameters, with MCA pulsatility index (PI) prespecified as the primary TCD variable. Repeat measurements at 24 hours will be performed only in patients who have not developed early neurological deterioration and when clinically feasible and safe. These assessments are observational and are used for early risk stratification; no therapeutic intervention is assigned as part of the study. Research procedures will not delay or interfere with standard clinical care.
Early Neurological Deterioration (END) within 24 hours
Early neurological deterioration (END) will be defined as a new or worsening neurological abnormality attributable to traumatic brain injury, including: (1) a decrease in Glasgow Coma Scale (GCS) score of 2 or more points from baseline when clinically assessable; (2) a new pupillary abnormality; or (3) a new focal neurological deficit not present at baseline. END is recorded independently of subsequent escalation of care or neurosurgical intervention.
Time frame: Within 24 hours of Emergency Department presentation
Radiological progression of traumatic brain injury
Radiological progression of traumatic intracranial injury on repeat CT brain imaging within 24 hours, when repeat CT is clinically indicated as part of standard care.
Time frame: Within 24 hours after Emergency Department presentation.
Escalation of neurological management
Escalation of neurological management within 24 hours, including emergency neurosurgical intervention, external ventricular drainage, or other intracranial pressure-directed intervention.
Time frame: Within 24 hours after Emergency Department presentation
In-hospital mortality
Death from any cause occurring before hospital discharge.
Time frame: From Emergency Department presentation until hospital discharge or death, whichever occurs first.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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