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

Phase 1

Recruiting

• Conditions: TBI Traumatic Brain Injury
• Interventions: Drug: control; Drug: propranolol; Drug: Carvedilol

• Registration Number: NCT06836856
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-20
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	control	-
propranolol	propranolol	propranolol
carvedilol	Carvedilol	Carvid (carvedilol)

Primary Outcome Measures

Name	Time	Method
Incidence of In-hospital mortality	14 days	Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment

Trial Locations

Locations (2)

Zagazig University Hospitals, Zagazig,; 🇪🇬 Zagazig, Egypt

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt