Traumatic Brain InjuryTCD TBINCT07107997
Transcranial Doppler in Traumatic Brain Edema
An observational study of Traumatic Brain Injury, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the role of transcranial Doppler (TCD) in evaluating brain edema in traumatic brain injury. The main question it aims to answer is: Is TCD equivalent to brain computerized tomography (CT) in evaluating traumatic brain edema? Participants will be examined by both methods at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2024to 13 Jun 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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: patients admitted to Critical Care Medicine Department in Alexandria University Hospitals
Who may be able to join
- Patients with brain edema following traumatic brain injury, admitted within 24 hours
Who cannot join
- Patients presented by out of hospital cardiac arrest or in-hospital cardiac arrest before performing the transcranial Doppler.
- Pregnant females.
- Inability to obtain adequate ultrasound window.
- Temporal bone fracture or brain herniation.
- Open head injuries or patients in need for surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Doppler Versus Computed Tomography In Evaluation Of Brain Edema In Patients With Traumatic Brain Injury
The goal of this clinical trial is to assess the role of transcranial Doppler (TCD) in evaluating brain edema in traumatic brain injury. The main question it aims to answer is:
Is TCD equivalent to brain computerized tomography (CT) in evaluating traumatic brain edema?
Participants will be examined by both methods at the same time to assess the correlation between them.
Read the detailed description
Computed Tomography (CT) scan of the brain will be done on admission to the ICU and 48-72 hours after starting hyperosmolar therapy. The cerebral oedema will be scored as follows: 0 = no brain oedema, 1 = mild brain oedema, 2 = moderate brain oedema, and 3 = severe brain oedema. Oedema is defined as mild when the ventricles and cisterns are narrow in the CT in the acute stage; moderate, when in addition to the mild form, the sylvian fissure and cortical gyri are not visualized; and severe, when in addition to mild and moderate, the perimesencephalic cisterns can not be visualized.
Transcranial doppler ultrasonography will be performed immediately after CT scan then after 48-72 hours of starting hyperosmolar therapy according to the following protocol:
- The examination will be done using phased array probe using (Versana active, general electric medical systems china Co.Ltd) ultrasound (US) device.
- Standing behind the head of the patient, the 2 Mega Hertz (MHz) transducer will be placed over the temporal area just above the zygomatic arch and in front of the tragus of the ear and oriented slightly upward and anteriorly.
- A red color signal (i.e. flow towards the probe) at a depth between 40-65 mm will represent the flow in the ipsilateral middle cerebral artery.
- The angle and position of insonation will be adjusted to provide the highest quality Doppler signal.
- By applying pulsed wave on the insonated segment, Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) will be measured and recorded on US machine.
- Mean flow velocity (MFV) will be calculated using the formula: (PSV+(EDVx 2))/3.
- Pulsatility index (PI) is calculated using the formula: (PSV-EDV)/ MFV.
- Intracranial pressure (ICP) will be calculated as follows:
- CPP is calculated as: MAP*(EDV /MFV) + 14. where MAP is the mean arterial blood pressure.
- ICP is then calculated as: MAP - CPP.
All patients in the study will be managed using the same management principles of traumatic brain injury with raised intracranial pressure such as:
- Hyperosmolar therapy either with 20% mannitol or 3% hypertonic saline.
- Control fever and seizures.
- Elevate head of bed 30-45.
- Adequate analgesia and sedation.
- Maintain systolic blood pressure > 90 mmHg.
- Maintain partial pressure of carbon dioxide (PaCo2) between 35-38 mmHg.
- Maintain partial pressure of oxygen (Pao2) between 80-120 mmHg.
- Avoid hyponatremia.
- Maintain Hb > 9 g/dL.
- Conditions
- Traumatic Brain Injury
- Keywords
- Transcranial Doppler, Traumatic brain injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury patients | Traumatic brain injury patients, with brain edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between transcranial Doppler and brain CT in assessment of brain edema
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start13 Oct 2024
- Primary completion13 Apr 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- 70 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107997
- Sponsor's protocol ID
- 0108653
- Acronym
- TCD TBI
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler Versus Computed Tomography In Evaluation Of Brain Edema In Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07107997
- Acronym / sponsor ID
- TCD TBI / 0108653
- Conditions
- Traumatic Brain Injury
- Keywords
- Transcranial Doppler, Traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 13 Oct 2024 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 6 Aug 2025 (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 goal of this clinical trial is to assess the role of transcranial Doppler (TCD) in evaluating brain edema in traumatic brain injury. The main question it aims to answer is:
Is TCD equivalent to brain computerized tomography (CT) in evaluating traumatic brain edema?
Participants will be examined by both methods at the same time to assess the correlation between them.
Detailed description
Computed Tomography (CT) scan of the brain will be done on admission to the ICU and 48-72 hours after starting hyperosmolar therapy. The cerebral oedema will be scored as follows: 0 = no brain oedema, 1 = mild brain oedema, 2 = moderate brain oedema, and 3 = severe brain oedema. Oedema is defined as mild when the ventricles and cisterns are narrow in the CT in the acute stage; moderate, when in addition to the mild form, the sylvian fissure and cortical gyri are not visualized; and severe, when in addition to mild and moderate, the perimesencephalic cisterns can not be visualized.
Transcranial doppler ultrasonography will be performed immediately after CT scan then after 48-72 hours of starting hyperosmolar therapy according to the following protocol:
- The examination will be done using phased array probe using (Versana active, general electric medical systems china Co.Ltd) ultrasound (US) device.
- Standing behind the head of the patient, the 2 Mega Hertz (MHz) transducer will be placed over the temporal area just above the zygomatic arch and in front of the tragus of the ear and oriented slightly upward and anteriorly.
- A red color signal (i.e. flow towards the probe) at a depth between 40-65 mm will represent the flow in the ipsilateral middle cerebral artery.
- The angle and position of insonation will be adjusted to provide the highest quality Doppler signal.
- By applying pulsed wave on the insonated segment, Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) will be measured and recorded on US machine.
- Mean flow velocity (MFV) will be calculated using the formula: (PSV+(EDVx 2))/3.
- Pulsatility index (PI) is calculated using the formula: (PSV-EDV)/ MFV.
- Intracranial pressure (ICP) will be calculated as follows:
- CPP is calculated as: MAP*(EDV /MFV) + 14. where MAP is the mean arterial blood pressure.
- ICP is then calculated as: MAP - CPP.
All patients in the study will be managed using the same management principles of traumatic brain injury with raised intracranial pressure such as:
- Hyperosmolar therapy either with 20% mannitol or 3% hypertonic saline.
- Control fever and seizures.
- Elevate head of bed 30-45.
- Adequate analgesia and sedation.
- Maintain systolic blood pressure > 90 mmHg.
- Maintain partial pressure of carbon dioxide (PaCo2) between 35-38 mmHg.
- Maintain partial pressure of oxygen (Pao2) between 80-120 mmHg.
- Avoid hyponatremia.
- Maintain Hb > 9 g/dL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury patients | – | –Traumatic brain injury patients, with brain edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to Critical Care Medicine Department in Alexandria University Hospitals
Key inclusion criteria (1 listed)
- Patients with brain edema following traumatic brain injury, admitted within 24 hours
Key exclusion criteria (5 listed)
- Patients presented by out of hospital cardiac arrest or in-hospital cardiac arrest before performing the transcranial Doppler.
- Pregnant females.
- Inability to obtain adequate ultrasound window.
- Temporal bone fracture or brain herniation.
- Open head injuries or patients in need for surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between transcranial Doppler and brain CT in assessment of brain edema
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury, run by Alexandria University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 12 Aug 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between transcranial Doppler and brain CT in assessment of brain edema (time frame: 72 hours). 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 12 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.