TBI Traumatic Brain InjuryPhase 1/2NCT06836856
Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury
A Phase 1/2 study testing propranolol and Carvedilol in people with TBI Traumatic Brain Injury, run by Mansoura University at 2 sites in Egypt.
Trial summary
Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TBI Traumatic Brain Injury
- What is being tested?
- propranolol and Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jan 2025to Jun 2025
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with moderate \& severe TBI detected on admission by CT scan and GCS score of ≤ 13 who either do not have any other injuries or only have associated minor injuries.
- Minor injuries are defined as presence of any of the following:
- Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.
- mild lung contusion detected in the chest CT scan.
- hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.
- simple limb fractures.
Who cannot join
- Patients on pre-injury beta-blocker therapy.
- Patients with any bronchospastic conditions.
- Patients with active acute coronary syndrome.
- TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:
- Moderate \& marked IPFF requiring surgical intervention ( laparotomy ).
- moderate \& marked lung contusion, pneumothorax \& hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.
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- Compound fracture in the upper or lower limb.
- Open Faciomaxillary trauma.
- Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4, or oliguria , HR < 60 b/min ) after > one week of admission.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Zagazig University Hospitals, Zagazig,
Zagazig
- Not yet recruiting
Zagazig University Hospitals
Zagazig
About this study
Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. The receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in TBI. Therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.
- Conditions
- TBI Traumatic Brain Injury
- Being tested
- control, propranolol, Carvedilol
- 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.
controlDrug
Patients will receive standard care with no interventions until end of treatment.
propranololDrug
starting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment.
CarvedilolDrug
starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Not described Receives: Drug: control |
| propranolol | Active comparator | propranolol Receives: Drug: propranolol |
| carvedilol | Active comparator | Carvid (carvedilol) Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of In-hospital mortality
Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Mansoura 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836856
- Sponsor's protocol ID
- 2024-37
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06836856
- Acronym / sponsor ID
- 2024-37
- Conditions
- TBI Traumatic Brain Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Feb 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.
Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. The receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in TBI. Therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: control |
| propranolol | Active comparator | Drug: propranololpropranolol |
| carvedilol | Active comparator | Drug: CarvedilolCarvid (carvedilol) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Patients with moderate \& severe TBI detected on admission by CT scan and GCS score of ≤ 13 who either do not have any other injuries or only have associated minor injuries.
- Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.
- mild lung contusion detected in the chest CT scan.
- hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.
- simple limb fractures.
Key exclusion criteria (9 listed)
- Patients on pre-injury beta-blocker therapy.
- Patients with any bronchospastic conditions.
- Patients with active acute coronary syndrome.
- TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:
- Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4, or oliguria , HR < 60 b/min ) after > one week of admission.
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 |
|---|---|---|
| controlPatients will receive standard care with no interventions until end of treatment. | Drug | Control Arm |
| propranololstarting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment. | Drug | propranolol |
| Carvedilolstarting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment. | Drug | carvedilol |
Primary outcome
Incidence of In-hospital mortality
Time frame: 14 days
Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment
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 2 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing propranolol and Carvedilol in people with TBI Traumatic Brain Injury, run by Mansoura University at 2 sites 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Aya Osama Nagaty (00201097721011, doctoraya_15@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of In-hospital mortality (time frame: 14 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 2 Apr 2025.