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TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury

ConditionTraumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with Traumatic Brain Injury1 intervention

Trial outcomes

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.

Time frame
Within 24 hours of Emergency Department presentation

Secondary outcomes

1

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.
2

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
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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