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NOT YET RECRUITING
NCT07820527

TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury

Sponsor: Assiut University

View on ClinicalTrials.gov

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.

Official title: Combined Transcranial Doppler and Optic Nerve Sheath Diameter for Early Risk Stratification of Patients With Traumatic Brain Injury in the Emergency Department

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-10

Completion Date

2028-05

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Assiut University Hospitals

Asyut, Asyut Governorate, Egypt