An observational study in Traumatic Brain Injuries and Brain Injuries,Traumatic, sponsored by Inonu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Inonu University · Observational
The purpose of this study is to find out whether blood flow measurements of the brain and neck arteries, obtained with bedside Doppler ultrasonography are associated with neurological outcome and survival in adult patients with traumatic brain injury treated in the intensive care unit. Transcranial and carotid Doppler examinations are performed at three time points during the intensive care stay. Regional cerebral oxygen saturation is also monitored with near-infrared spectroscopy when the device is available. The study does not change patient treatment; all measurements are non-invasive and are performed alongside routine care.
Traumatic brain injury (TBI) is a leading cause of death and disability and early identification of patients at high risk of poor outcome remains challenging. Transcranial Doppler (TCD) and carotid Doppler ultrasonography are non-invasive bedside tools that reflect cerebral hemodynamics and may provide prognostic information.
This prospective observational cohort study is conducted in the Anesthesiology and Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center, Malatya, Türkiye. Adult patients admitted with TBI are enrolled after informed consent is obtained from a legally authorized representative.
Doppler measurements are obtained at three time points: within the first 24 hours after ICU admission (T1), at 72 hours (T2), and on day 7 when clinically feasible (T3). Measurements are taken from the common carotid, internal carotid, external carotid, and middle cerebral arteries. Recorded parameters include peak systolic velocity, end-diastolic velocity, time-averaged mean velocity, pulsatility index, and resistive index. Regional cerebral oxygen saturation (rSO2) is monitored with near-infrared spectroscopy when the device is available; if it cannot be obtained, the study will be completed using Doppler and clinical parameters.
The primary outcome is the association between middle cerebral artery pulsatility index and neurological outcome assessed by the Glasgow Outcome Scale / Glasgow Outcome Scale-Extended at 30 days. Secondary outcomes include the association of carotid artery Doppler indices with 30-day mortality, their correlation with Glasgow Coma Scale score, intensive care unit length of stay, and duration of mechanical ventilation, and the predictive performance of Doppler parameters for poor neurological outcome. The planned sample size is approximately 110 patients.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's planned enrollment of 110 is close to the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Inonu University is the lead sponsor of 384 studies on the registry; 90 are open to participants now.
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Adult patients admitted to the Anesthesiology and Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center with traumatic brain injury.
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Exclusion Criteria:
Adult patients with traumatic brain injury admitted to the intensive care unit who undergo serial transcranial and carotid Doppler ultrasonography within the first 24 hours after admission, at 72 hours, and on day 7 when clinically feasible.
Diagnostic Test: Transcranial and Carotid Doppler Ultrasonography
Non-invasive bedside Doppler measurement of peak systolic velocity, end-diastolic velocity, time-averaged mean velocity, pulsatility index, and resistive index in the common carotid, internal carotid, external carotid, and middle cerebral arteries.
Association Between Middle Cerebral Artery Pulsatility Index and Neurological Outcome
Middle cerebral artery pulsatility index measured by transcranial Doppler within the first 24 hours after ICU admission, at 72 hours, and on day 7 when clinically feasible will be analyzed for its association with neurological outcome assessed by the Glasgow Outcome Scale / Glasgow Outcome Scale-Extended (GOS/GOSE).
Time frame: 30 days after ICU admission
Association Between Carotid Artery Doppler Indices and Mortality
Pulsatility index and resistive index of the common carotid, internal carotid, and external carotid arteries will be analyzed for their association with all-cause mortality.
Time frame: 30 days after ICU admission
Correlation Between Doppler Indices and Glasgow Coma Scale Score
Pulsatility index and resistive index values will be correlated with the Glasgow Coma Scale score recorded at each Doppler measurement time point.
Time frame: Within 24 hours, at 72 hours, and on day 7 after ICU admission
Association Between Doppler Indices and ICU Length of Stay
Pulsatility index and resistive index values will be analyzed for their association with the length of intensive care unit stay in days.
Time frame: From ICU admission to ICU discharge or death, up to 30 days
Association Between Doppler Indices and Duration of Mechanical Ventilation
Pulsatility index and resistive index values will be analyzed for their association with the duration of invasive mechanical ventilation in days.
Time frame: From ICU admission to extubation or death, up to 30 days
Predictive Performance of Doppler Parameters for Poor Neurological Outcome
The ability of transcranial and carotid Doppler parameters to predict poor neurological outcome will be evaluated using receiver operating characteristic (ROC) curve analysis, with area under the curve, sensitivity, and specificity reported.
Time frame: 30 days after ICU admission
Plan to share: No — Individual participant data will not be shared due to patient confidentiality and the absence of consent for data sharing beyond the study team. Aggregate results will be published in a peer-reviewed journal.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 239 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 86. This study's planned 14 months is below that.
Counting every sponsor, half of 265 studies reached it within 45 months; a quarter within 22 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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