Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury

March 27, 2025 updated by: Noha Mansour, Mansoura University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Recruiting
        • Zagazig University Hospitals, Zagazig,
      • Zagazig, Egypt
        • Not yet recruiting
        • Zagazig University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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:

  1. Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.
  2. mild lung contusion detected in the chest CT scan.
  3. hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.
  4. simple limb fractures.

Exclusion Criteria:

  1. Patients on pre-injury beta-blocker therapy.
  2. Patients with any bronchospastic conditions.
  3. Patients with active acute coronary syndrome.

  4. TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:

    1. Moderate & marked IPFF requiring surgical intervention ( laparotomy ).
    2. moderate & marked lung contusion, pneumothorax & hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.
    3. Compound fracture in the upper or lower limb.
    4. Open Faciomaxillary trauma.
  5. Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4, or oliguria , HR < 60 b/min ) after > one week of admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Arm
Drug: control
Patients will receive standard care with no interventions until end of treatment.
Active Comparator: propranolol
Drug: propranolol
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.
Active Comparator: carvedilol
Carvid (carvedilol)
Drug: Carvedilol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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