Trauma, BrainNCT05151978
Transcranial Doppler in Mild and Moderate Traumatic Brain Injury (TBI)
An observational study of Trauma, Brain, run by Tanta University at 1 site in Egypt.
Trial summary
Utility of transcranial Doppler as an Early Predictor of Neurological deterioration in Mild and Moderate Traumatic Brain Injury Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Trauma, Brain
- What is being tested?
- Transcranial Doppler
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2021to 22 Feb 2022
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient with TBI
Who may be able to join
- patient with traumatic brain injury and glasgow coma scale 9_15
Who cannot join
- Unstable or patient on Mechanical ventilation, Sever brain injury , patient receive anticoagulant
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Tanta, 3511
aymen elghamry
hala elgendy
About this study
Official title: Transcranial Doppler as an Early Predictor of Neurological Outcome in Mild and Moderate Traumatic Brain Injury
Utility of transcranial Doppler as an Early Predictor of Neurological deterioration in Mild and Moderate Traumatic Brain Injury
Read the detailed description
Transcranial Doppler done to TBI patients on admission and follow up was done and Secondary Neurological deterioration was documented
- Conditions
- Trauma, Brain
- Being tested
- Transcranial Doppler
- Keywords
- Trans , cranial, TBI
- 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 DopplerDiagnostic test
Also called CT of the brain
Transcranial Doppler on middle cerebral arteries
| Study group | Role | What they receive |
|---|---|---|
| (glasgow coma scale) 9 _15 | No Secondary Neurological deterioration Receives: Diagnostic Test: Transcranial Doppler | |
| (glasgow coma scale) 9_15 | Secondary Neurological deterioration Receives: Diagnostic Test: Transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Neurological deterioration
Decrease in glasgow coma scale and /or deterioration need to surgical intervention
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start3 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion22 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, BrainStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Kamal, Tanta University
- Investigators
- Ahmed Goneim, Study chair, Head of faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151978
- Sponsor's protocol ID
- 33574/12/19
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data of transcranial Doppler of middle cerebral arteries and the Neurological outcome
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler as an Early Predictor of Neurological Outcome in Mild and Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05151978
- Acronym / sponsor ID
- 33574/12/19
- Conditions
- Trauma, Brain
- Keywords
- Trans , cranial, TBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 22 Feb 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
Utility of transcranial Doppler as an Early Predictor of Neurological deterioration in Mild and Moderate Traumatic Brain Injury
Detailed description
Transcranial Doppler done to TBI patients on admission and follow up was done and Secondary Neurological deterioration was documented
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (glasgow coma scale) 9 _15 | – | Diagnostic Test: Transcranial DopplerNo Secondary Neurological deterioration |
| (glasgow coma scale) 9_15 | – | Diagnostic Test: Transcranial DopplerSecondary Neurological deterioration |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with TBI
Key inclusion criteria (1 listed)
- patient with traumatic brain injury and glasgow coma scale 9_15
Key exclusion criteria (1 listed)
- Unstable or patient on Mechanical ventilation, Sever brain injury , patient receive anticoagulant
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 DopplerAlso: CT of the brainTranscranial Doppler on middle cerebral arteries | Diagnostic test | (glasgow coma scale) 9 _15, (glasgow coma scale) 9_15 |
Primary outcome
Secondary Neurological deterioration
Time frame: 7 days
Decrease in glasgow coma scale and /or deterioration need to surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- https://pubmed.ncbi.nlm.nih.gov/31497078/Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data of transcranial Doppler of middle cerebral arteries and the Neurological outcome
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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.
Ahmed Goneim study chair
Head of faculty of medicine
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 Trauma, Brain, run by Tanta 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 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelhafez (02040547758, Ahmed.abdelhafez@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary Neurological deterioration (time frame: 7 days). 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 9 Dec 2021.