Actively Recruiting
Evaluating the Impact of Adjuvant Beta Blockers Propranolol and Carvedilol on Clinical Outcomes in Patients With Traumatic Brain Injury
Led by Mansoura University · Updated on 2025-04-02
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of different beta blockers on patients with moderate to severe traumatic brain injury (TBI). This trial compares propranolol, which blocks beta-1 and beta-2 adrenergic receptors, with carvedilol, which blocks these receptors plus alpha-1 receptors. The study aims to understand how these differences in receptor targeting might influence brain injury outcomes and survival after TBI. Participants are randomly assigned to one of three groups: a control group receiving standard care without beta blockers, a propranolol group starting at 20 mg three times daily with dose increases until the heart rate is under 100 beats per minute (up to 640 mg/day), or a carvedilol group starting at 6.25 mg three times daily with similar dose increases up to 100 mg/day. All doses are given orally or via feeding tube alongside standard care, continuing until the end of treatment. During the study, participants will be monitored for heart rate and vital signs. The main outcome measured is the incidence of death within 14 days of hospital admission. The trial includes adults aged 18 to 75 with moderate or severe TBI confirmed by CT scan and a Glasgow Coma Scale score of 13 or less. The study uses a single-blind design and is sponsored by Mansoura University.
CONDITIONS
Brief Title
Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate or severe traumatic brain injury confirmed by CT scan and Glasgow Coma Scale score of 13 or less
- Patients with no other injuries or only minor associated injuries such as mild free fluid in the abdomen, mild lung contusion, hemothorax or pneumothorax without breathing symptoms, or simple limb fractures
- Adults aged 18 to 75 years
You will not qualify if you...
- Patients already on beta blocker therapy before injury
- Patients with bronchospastic conditions like asthma
- Patients with active acute coronary syndrome
- Patients with traumatic brain injury and major associated injuries requiring surgery, such as significant abdominal fluid or lung contusions with symptoms, compound limb fractures, open facial trauma
- Patients with persistent shock after more than one week of admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive either propranolol, carvedilol, or standard care without beta blockers. Medication doses are adjusted daily to reach a target heart rate until the end of treatment.
Daily visits for up to 14 days
Trial Site Locations
Total: 2 locations
1
Zagazig University Hospitals, Zagazig,
Zagazig, Egypt
Actively Recruiting
2
Zagazig University Hospitals
Zagazig, Egypt
Not Yet Recruiting
Research Team
A
Aya Osama Nagaty
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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