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NCT07820527
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Assiut University
Location: Assiut University Hospitals Asyut Asyut Governorate
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.
Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18 years or older.
2. Acute traumatic brain injury diagnosed clinically and/or radiologically.
3. Initial Glasgow Coma Scale (GCS) score ≤13.
4. Initial CT brain scan demonstrating a traumatic intracranial structural lesion.
5. No indication for immediate neurosurgical intervention at initial assessment.
6. Initially managed conservatively/non-operatively according to the treating team.
7. Informed consent obtained from the patient or legally authorized representative.
Exclusion Criteria:
1. Immediate neurosurgical indication requiring urgent intervention.
2. Immediate life-saving procedure or clinical instability preventing safe completion of the research ultrasound assessment.
3. Significant orbital trauma or ocular pathology interfering with reliable optic nerve sheath diameter measurement.
4. Previous decompressive craniectomy.
5. Inadequate temporal acoustic window preventing reliable middle cerebral artery transcranial Doppler assessment.
6. Refusal to participate or withdrawal of consent.
Source: ClinicalTrials.gov (NCT07820527). StuddyBuddy aggregates publicly available trial information.