Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI

NCT06870370 | Not Yet Recruiting Phase 3

• 1 other identifier: 36264MS291/8/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

Conditions

Traumatic Brain Injury (TBI) Patients; Intracranial Pressure; Intensive Care Unit; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality in severe traumatic brain injury with usage of β blocker

  7 days

Secondary Outcomes (1)

• Glascow outcome scale extended

  7 days

Study Arms (2)

Propranolol group

EXPERIMENTAL

This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.

Drug: propranolol

normal saline IV group

PLACEBO COMPARATOR

This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Drug: normal saline IV

Interventions

propranolol DRUG

This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg

Also known as: Experimental group

Propranolol group

normal saline IV DRUG

This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Also known as: control group

normal saline IV group

Eligibility Criteria

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

You may qualify if:

• Patients aged between 18and 65 years old
• Patients who have Severe traumatic brain injury
• Glascow outcome scale ≤ 8

You may not qualify if:

• Patients have pre-existing heart disease.
• If there are contraindications to β blocker.
• penetrating traumatic brain injury.
• pre-injury brain dysfunction.
• β-blocker or α2-agonist use before trauma.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol; Control Groups

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; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Huda Elkallaf, Resident

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huda Elkallaf, Resident

CONTACT

022 0 10 96213750; hoda171661_pg@med.tanta.edu.eg

Huda Elkallaf, Resident

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Emergency Medicine and Traumatology

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: September 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For one year

Locations

EG (1)