Traumatic Brain InjuriesNCT07890259
Doppler Ultrasonography Parameters and Mortality in Traumatic Brain Injury
An observational study of Traumatic Brain Injuries and Brain Injuries,Traumatic, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injuries, Brain Injuries,Traumatic
- What is being tested?
- Transcranial and Carotid Doppler Ultrasonography
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the Anesthesiology and Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center with traumatic brain injury.
Who may be able to join
- Age 18 years or older
- Admission to the intensive care unit with a diagnosis of traumatic brain injury
- Informed consent obtained from the patient or a legally authorized representa
Who cannot join
- Inadequate acoustic temporal window preventing transcranial Doppler measurement
- Known pre-existing significant carotid or intracranial arterial stenosis or occlusion
- Pregnancy
- Death or ICU discharge before the first Doppler measurement could be obtained
- Refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center
Malatya, Bursa, 44280
Göksel Aydoğan, MD, 05342428048 ext. +905342428048, drgoksel5533@gmail.com
Ayşe Belin Özer, MD, Prof., +905334478924, belin.ozer@inonu.edu.tr
About this study
Official title: Prognostic Value of Serial Transcranial and Carotid Doppler Ultrasonography Parameters for 30-Day Mortality in Patients With Traumatic Brain Injury in the Intensive Care Unit: A Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injuries, Brain Injuries,Traumatic
- Being tested
- Transcranial and Carotid Doppler Ultrasonography
- Keywords
- Transcranial Doppler Ultrasonography, Carotid Doppler, Pulsatility Index, Resistive Index, Cerebral Hemodynamics, Near-Infrared Spectroscopy, Intensive Care Unit
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial and Carotid Doppler UltrasonographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Traumatic Brain Injury | 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. Receives: Diagnostic Test: Transcranial and Carotid Doppler Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days after ICU admission
Secondary outcomes (2)
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.
Measured: 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.
Measured: Within 24 hours, at 72 hours, and on day 7 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
- Investigators
- Ayşe Belin Özer, MD, Prof., Principal investigator, Inonu University Turgut Ozal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890259
- Sponsor's protocol ID
- 10811
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serial Transcranial and Carotid Doppler Ultrasonography Parameters for 30-Day Mortality in Patients With Traumatic Brain Injury in the Intensive Care Unit: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07890259
- Acronym / sponsor ID
- 10811
- Conditions
- Traumatic Brain Injuries, Brain Injuries,Traumatic
- Keywords
- Transcranial Doppler Ultrasonography, Carotid Doppler, Pulsatility Index, Resistive Index, Cerebral Hemodynamics, Near-Infrared Spectroscopy, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Traumatic Brain Injury | – | Diagnostic Test: Transcranial and Carotid Doppler UltrasonographyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the Anesthesiology and Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center with traumatic brain injury.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Admission to the intensive care unit with a diagnosis of traumatic brain injury
- Informed consent obtained from the patient or a legally authorized representa
Key exclusion criteria (5 listed)
- Inadequate acoustic temporal window preventing transcranial Doppler measurement
- Known pre-existing significant carotid or intracranial arterial stenosis or occlusion
- Pregnancy
- Death or ICU discharge before the first Doppler measurement could be obtained
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial and Carotid Doppler UltrasonographyNon-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. | Diagnostic test | Patients With Traumatic Brain Injury |
Primary outcome
Association Between Middle Cerebral Artery Pulsatility Index and Neurological Outcome
Time frame: 30 days after ICU admission
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).
2 secondary outcomes
Association Between Carotid Artery Doppler Indices and Mortality
Time frame: 30 days after ICU admission
Correlation Between Doppler Indices and Glasgow Coma Scale Score
Time frame: Within 24 hours, at 72 hours, and on day 7 after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe Belin Özer, MD, Prof. principal investigator
Inonu University Turgut Ozal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injuries and Brain Injuries,Traumatic, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Göksel Aydoğan, MD (+905342428048, drgoksel5533@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Middle Cerebral Artery Pulsatility Index and Neurological Outcome (time frame: 30 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.