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

Mansoura University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: TBI Traumatic Brain Injury

Treatments: Drug: control; Drug: propranolol; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT06836856

2024-37

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups, including a placebo group

Control Arm

Placebo Comparator group

Treatment:

Drug: control

propranolol

Active Comparator group

Description:

propranolol

Treatment:

Drug: propranolol

carvedilol

Active Comparator group

Description:

Carvid (carvedilol)

Treatment:

Drug: Carvedilol