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

Last updated: March 27, 2025
Sponsor: Mansoura University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neurologic Disorders

Treatment

control

propranolol

Carvedilol

Clinical Study ID

NCT06836856
2024-37
  • Ages 18-75
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with moderate & severe TBI detected on admission by CT scan and GCS scoreof ≤ 13 who either do not have any other injuries or only have associated minorinjuries.

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

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 ofthe following:

  5. Moderate & marked IPFF requiring surgical intervention ( laparotomy ).

  6. moderate & marked lung contusion, pneumothorax & hemothorax with accompanyingsymptoms of hypoxia, tachypnea, lower limbs, or limb amputation.

  7. Compound fracture in the upper or lower limb.

  8. Open Faciomaxillary trauma.

  9. Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4,or oliguria , HR < 60 b/min ) after > one week of admission.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: control
Phase: 1/2
Study Start date:
January 20, 2025
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Zagazig University Hospitals

    Zagazig,
    Egypt

    Site Not Available

  • Zagazig University Hospitals, Zagazig,

    Zagazig,
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.