Trauma, BrainPhase 4NCT05195996
Beta Blocker Effects in Traumatic Brain Injury
A Phase 4 study testing Propranolol and Saline in people with Trauma, Brain, run by Menoufia University at 1 site in Egypt.
Trial summary
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Trauma, Brain
- What is being tested?
- Propranolol and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 31 May 2022
- Phase
- Phase 4
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- GCS preoperative >10
- Abbreviated Injury Scale (AIS) >3
- Length stay in ICU >48 h
Who cannot join
- Hypersensitivity to propranolol
- Asthmatic patient
- COPD
- History of smoking
- Any cardiac problems eg: ( heart failure or HB )
- pheochromocytoma
Show all 12Show fewer
- Pregnant patient
- Length stay <48h
- Death within 48 h of admission
- Patient who previously received any beta blocker at home.
- Symptomatic Bradycardia <60 b/m (sick sinus syndrome)
- Hemodynamic unstable patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, University Hospitals
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Beta Blocker Effects on Patients With Traumatic Brain Injury
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.
Read the detailed description
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups.
Parameters assessment:
- Length of ICU stay
- Length of total hospital stay
- CT scan to exclude another intracranial hemorrhage or increase in hemorrhage
- Functional status will be assessed using the GCS
- Hemodynamic data ( bl.p / hr )
- Crystalloid volume that patient need in 24h
- Mortality rate
- Conditions
- Trauma, Brain
- Being tested
- Propranolol, Saline
- 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
intravenous propranolol for case patients
SalineDrug
intravenous saline for placebo
| Study group | Role | What they receive |
|---|---|---|
| beta blocker | Active comparator | Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours Receives: Drug: Propranolol |
| placebo | Placebo comparator | Will be given normal saline 10 ml every 6 hours for 48 hours Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
number of surviving in patients receiving propranolol and patients who did not receive any beta blocker
Measured: 7 days
Secondary outcomes (2)
heart rate
number of patient showing effect of beta blocker on TBI related to HR
Measured: 7 days
icu stay
number of patients were beta blocker in TBI affected on ICU and total hospital stay
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 posted19 Jan 2022
- Study start1 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 May 2022
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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
- Investigators
- mostafa f mansour, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195996
- Sponsor's protocol ID
- 2/2021ANESTH-4
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Blocker Effects on Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05195996
- Acronym / sponsor ID
- 2/2021ANESTH-4
- Conditions
- Trauma, Brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Jan 2022 (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 study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.
Detailed description
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups.
Parameters assessment:
- Length of ICU stay
- Length of total hospital stay
- CT scan to exclude another intracranial hemorrhage or increase in hemorrhage
- Functional status will be assessed using the GCS
- Hemodynamic data ( bl.p / hr )
- Crystalloid volume that patient need in 24h
- Mortality rate
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beta blocker | Active comparator | Drug: PropranololWill be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours |
| placebo | Placebo comparator | Drug: SalineWill be given normal saline 10 ml every 6 hours for 48 hours |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- GCS preoperative >10
- Abbreviated Injury Scale (AIS) >3
- Length stay in ICU >48 h
Key exclusion criteria (12 listed)
- Hypersensitivity to propranolol
- Asthmatic patient
- COPD
- History of smoking
- Any cardiac problems eg: ( heart failure or HB )
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 |
|---|---|---|
| Propranololintravenous propranolol for case patients | Drug | beta blocker |
| Salineintravenous saline for placebo | Drug | placebo |
Primary outcome
survival
Time frame: 7 days
number of surviving in patients receiving propranolol and patients who did not receive any beta blocker
2 secondary outcomes
heart rate
Time frame: 7 days
icu stay
Time frame: 7 days
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 17 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
mostafa f mansour, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol and Saline in people with Trauma, Brain, run by Menoufia 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 12 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 17 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
survival (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 17 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.