Traumatic Brain Injury (TBI) PatientsPhase 3NCT06870370
Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI
A Phase 3 study testing propranolol and normal saline IV in people with Traumatic Brain Injury (TBI) Patients and Intracranial Pressure, run by Tanta University at 1 site in Egypt.
Trial summary
The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Intracranial Pressure, Intensive Care Unit
- What is being tested?
- propranolol and normal saline IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 20 Sep 2025
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18and 65 years old
- Patients who have Severe traumatic brain injury
- Glascow outcome scale ≤ 8
Who cannot join
- Patients have pre-existing heart disease.
- If there are contraindications to β blocker.
- penetrating traumatic brain injury.
- pre-injury brain dysfunction.
- β-blocker or α2-agonist use before trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huda Elkallaf, Resident contact
Egypt1 site
Tanta University
Tanta, 31527
Huda Elkallaf, Resident, +20 10 96213750, hoda171661_pg@med.tanta.edu.eg
About this study
Official title: Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury
The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury
Read the detailed description
The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.
Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .
β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .
A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.
- Conditions
- Traumatic Brain Injury (TBI) Patients, Intracranial Pressure, Intensive Care Unit, Mortality
- Being tested
- propranolol, normal saline IV
- 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.
propranololDrug
Also called Experimental group
This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg
normal saline IVDrug
Also called control group
This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Propranolol group | Experimental | This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days. Receives: Drug: propranolol |
| normal saline IV group | Placebo comparator | This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days Receives: Drug: normal saline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in severe traumatic brain injury with usage of β blocker
Measured: 7 days
Secondary outcomes (1)
Glascow outcome scale extended
Glascow outcome scale extended) consists of 8 categories:
Death Persistent vegetative state: awake not aware. Lower severe disability: dependent, require help most of time. Upper severe disability: dependent, can be left alone some time. Iower moderate disability: independent, unable to work. Upper moderate disability: independent, reduced work capacity. Lower good recovery: minor problems that affect daily activities. Upper good recovery: no current problems related to brain injury.
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 posted11 Mar 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Talaat Ibrahim Elkallaf, Tanta University
- Investigators
- Huda Elkallaf, Resident, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870370
- Sponsor's protocol ID
- 36264MS291/8/23
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06870370
- Acronym / sponsor ID
- 36264MS291/8/23
- Conditions
- Traumatic Brain Injury (TBI) Patients, Intracranial Pressure, Intensive Care Unit, Mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 11 Mar 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 role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury
Detailed description
The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.
Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .
β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .
A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol group | Experimental | Drug: propranololThis group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days. |
| normal saline IV group | Placebo comparator | Drug: normal saline IVThis group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18and 65 years old
- Patients who have Severe traumatic brain injury
- Glascow outcome scale ≤ 8
Key exclusion criteria (5 listed)
- Patients have pre-existing heart disease.
- If there are contraindications to β blocker.
- penetrating traumatic brain injury.
- pre-injury brain dysfunction.
- β-blocker or α2-agonist use before trauma.
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 |
|---|---|---|
| propranololAlso: Experimental groupThis group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg | Drug | Propranolol group |
| normal saline IVAlso: control groupThis group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days | Drug | normal saline IV group |
Primary outcome
Mortality
Time frame: 7 days
Mortality in severe traumatic brain injury with usage of β blocker
1 secondary outcome
Glascow outcome scale extended
Time frame: 7 days
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from principle investigator
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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.
Huda Elkallaf, Resident contact
Huda Elkallaf, Resident principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propranolol and normal saline IV in people with Traumatic Brain Injury (TBI) Patients and Intracranial Pressure, 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 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 11 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huda Elkallaf, Resident (022 0 10 96213750, hoda171661_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (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 11 Mar 2025.