Evaluating the effects of beta blockers on outcomes in traumatic brain injury patients

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

This study is testing whether beta blockers can help improve recovery for people with moderate to severe traumatic brain injuries.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mansoura University (Academic / other)
• Locations: 2 sites (Zagazig and 1 other locations)
• Trial ID: NCT06836856 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of adjuvant beta blockers, specifically propranolol and carvedilol, on clinical outcomes in patients suffering from moderate to severe traumatic brain injury (TBI). The study aims to understand how the different receptor blockade profiles of these medications may influence secondary brain injury processes and overall patient recovery. Patients will be monitored for their responses to the treatments compared to a control group, with a focus on improving outcomes for those with TBI. The trial is designed to gather data that could lead to better therapeutic strategies for managing TBI.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with moderate to severe TBI, as indicated by a GCS score of 13 or lower, who have minimal associated injuries.

Not a fit: Patients with pre-existing bronchospastic conditions or those on beta-blocker therapy prior to injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery outcomes for patients with traumatic brain injury through the use of beta blockers.

How similar studies have performed: While the use of beta blockers in TBI is a novel approach, preliminary studies have suggested potential benefits, but further investigation is needed to confirm these findings.

Eligibility criteria

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.

Where this trial is running

Zagazig and 1 other locations

• Zagazig University Hospitals, Zagazig, — Zagazig, Egypt (Recruiting)
• Zagazig University Hospitals — Zagazig, Egypt (Not_yet_recruiting)

Study contacts

• Study coordinator: Aya Osama Nagaty

Conditions TBI Traumatic Brain Injury