Traumatic Brain InjuryTCD-ONSDNCT07820527
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Transcranial Doppler and Optic Nerve Sheath Diameter Assessment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged 18 years or older.
- Acute traumatic brain injury diagnosed clinically and/or radiologically.
- Initial Glasgow Coma Scale (GCS) score ≤13.
- Initial CT brain scan demonstrating a traumatic intracranial structural lesion.
- No indication for immediate neurosurgical intervention at initial assessment.
- Initially managed conservatively/non-operatively according to the treating team.
- Informed consent obtained from the patient or legally authorized representative.
Who cannot join
- Immediate neurosurgical indication requiring urgent intervention.
- Immediate life-saving procedure or clinical instability preventing safe completion of the research ultrasound assessment.
- Significant orbital trauma or ocular pathology interfering with reliable optic nerve sheath diameter measurement.
- Previous decompressive craniectomy.
- Inadequate temporal acoustic window preventing reliable middle cerebral artery transcranial Doppler assessment.
- Refusal to participate or withdrawal of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospitals
Asyut, Asyut Governorate, 85811
Doaa Ellisy, MSc, +201111834281, doaaellisy@gmail.com
About this study
Official title: Combined Transcranial Doppler and Optic Nerve Sheath Diameter for Early Risk Stratification of Patients With Traumatic Brain Injury in the Emergency Department
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Transcranial Doppler and Optic Nerve Sheath Diameter Assessment
- Keywords
- Transcranial Doppler, Optic Nerve Sheath Diameter, ONSD, TCD, Neurological Deterioration, Intracranial Hypertension, Risk Stratification, Early Neurological Deterioration, MCA Pulsatility Index
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler and Optic Nerve Sheath Diameter AssessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Traumatic Brain Injury | 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. Receives: Diagnostic Test: Transcranial Doppler and Optic Nerve Sheath Diameter Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of Emergency Department presentation
Secondary outcomes (3)
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.
Measured: 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.
Measured: Within 24 hours after Emergency Department presentation
In-hospital mortality
Death from any cause occurring before hospital discharge.
Measured: From Emergency Department presentation until hospital discharge or death, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820527
- Sponsor's protocol ID
- AUEM-TCD-ONSD-2026
- Acronym
- TCD-ONSD
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Transcranial Doppler and Optic Nerve Sheath Diameter for Early Risk Stratification of Patients With Traumatic Brain Injury in the Emergency Department
- ClinicalTrials.gov ID
- NCT07820527
- Acronym / sponsor ID
- TCD-ONSD / AUEM-TCD-ONSD-2026
- Conditions
- Traumatic Brain Injury
- Keywords
- Transcranial Doppler, Optic Nerve Sheath Diameter, ONSD, TCD, Neurological Deterioration, Intracranial Hypertension, Risk Stratification, Early Neurological Deterioration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Traumatic Brain Injury | – | Diagnostic Test: Transcranial Doppler and Optic Nerve Sheath Diameter AssessmentAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Acute traumatic brain injury diagnosed clinically and/or radiologically.
- Initial Glasgow Coma Scale (GCS) score ≤13.
- Initial CT brain scan demonstrating a traumatic intracranial structural lesion.
- No indication for immediate neurosurgical intervention at initial assessment.
Key exclusion criteria (6 listed)
- Immediate neurosurgical indication requiring urgent intervention.
- Immediate life-saving procedure or clinical instability preventing safe completion of the research ultrasound assessment.
- Significant orbital trauma or ocular pathology interfering with reliable optic nerve sheath diameter measurement.
- Previous decompressive craniectomy.
- Inadequate temporal acoustic window preventing reliable middle cerebral artery transcranial Doppler assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler and Optic Nerve Sheath Diameter AssessmentTranscranial 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. | Diagnostic test | Patients with Traumatic Brain Injury |
Primary outcome
Early Neurological Deterioration (END) within 24 hours
Time frame: Within 24 hours of Emergency Department presentation
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.
3 secondary outcomes
Radiological progression of traumatic brain injury
Time frame: Within 24 hours after Emergency Department presentation.
Escalation of neurological management
Time frame: Within 24 hours after Emergency Department presentation
In-hospital mortality
Time frame: From Emergency Department presentation until hospital discharge or death, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa Ellisy, MSc in Emergency Medicine (+201111834281, doaaellisy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Neurological Deterioration (END) within 24 hours (time frame: Within 24 hours of Emergency Department presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.