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

NCT06836856 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

TBI Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of In-hospital mortality

  Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment

  14 days

Study Arms (3)

Control Arm

PLACEBO COMPARATOR

Drug: control

propranolol

ACTIVE COMPARATOR

propranolol

Drug: propranolol

carvedilol

ACTIVE COMPARATOR

Carvid (carvedilol)

Drug: Carvedilol

Interventions

control DRUG

Patients will receive standard care with no interventions until end of treatment.

Control Arm

propranolol DRUG

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.

propranolol

Carvedilol DRUG

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.

carvedilol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients on pre-injury beta-blocker therapy.
• Patients with any bronchospastic conditions.
• Patients with active acute coronary syndrome.
• TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:
• Moderate \& marked IPFF requiring surgical intervention ( laparotomy ).
• moderate \& marked lung contusion, pneumothorax \& hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.
• Compound fracture in the upper or lower limb.
• Open Faciomaxillary trauma.
• Patients with persistent shock (systemic blood pressure \<100 mmHg, base deficit \> 4, or oliguria , HR \< 60 b/min ) after \> one week of admission.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Zagazig University Hospitals, Zagazig,

Zagazig, Egypt

RECRUITING

Zagazig University Hospitals

Zagazig, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol; Carvedilol

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Aya Osama Nagaty

CONTACT

00201097721011; doctoraya_15@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 20, 2025
• Study Start: January 20, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)