TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury

NCT07820527 | Not Yet Recruiting

• 1 other identifier: AUEM-TCD-ONSD-2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Traumatic Brain Injury

Keywords

Transcranial Doppler; Optic Nerve Sheath Diameter; ONSD; TCD; Neurological Deterioration; Intracranial Hypertension; Risk Stratification; Early Neurological Deterioration; MCA Pulsatility Index

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 24 hours of Emergency Department presentation

Secondary Outcomes (3)

• Radiological progression of traumatic brain injury

  Within 24 hours after Emergency Department presentation.

• Escalation of neurological management

  Within 24 hours after Emergency Department presentation

• In-hospital mortality

  From Emergency Department presentation until hospital discharge or death, whichever occurs first.

Study Arms (1)

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.

Diagnostic Test: Transcranial Doppler and Optic Nerve Sheath Diameter Assessment

Interventions

Transcranial Doppler and Optic Nerve Sheath Diameter Assessment DIAGNOSTIC_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.

Patients with Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, Asyut Governorate, 85811, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Doaa Ellisy, MSc in Emergency Medicine

CONTACT

+201111834281; doaaellisy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

EG (1)