Beta Blockade in in Traumatic Brain Injury

Status Completed

Clinical Trial Summary

The purpose of this study is test the effect of beta-adrenergic blockade on mortality in patients with traumatic brain injury with the hypothesis being that the addition of beta blockade to the treatment regime of this patient population will lower mortality and supress the catecholamine surge that accompanies traumatic brain injury as compared to those who do not receive beta blockade.

Half the patients will be randomized to receive propranolol and half will be randomized to receive no beta blocker.

Clinical Trial Description

The use of Beta-adrenergic blockade is not currently the standard of care of patients with traumatic brain injury. Traumatic brain injury is a common problem in our society with greater than 1.5 million cases occurring annually and over 50,000 deaths per year in the civilian population in the United States. Medical therapy has long consisted of monitoring intracranial pressure and supportive measures designed to limit intracranial pressure. Two retrospective observational studies completed at the University of Tennessee demonstrate that the addition of beta-adrenergic blockage to the treatment of the traumatic brain injury lessens mortality. The basis for conducting this study was established by retrospective data showing no harm to patients receiving Inderal and potential benefit. Available data, including data from the University of Tennessee, are retrospective and are limited to simple exposure to the drug. The proposed study will attempt to further quantify the effect by dosing with the drug to actual beta-blockade instead of simple exposure to the drug.

The effect of propranolol at the dosing levels used in this research will be determined by measurement of urinary catecholamines in both study arms and comparison of the actual effect of the drug on the catecholamine surge that occurs following traumatic brain injury will be determined.

Additionally, the effect of healthcare disparities on outcomes in patients with traumatic brain injury will be measured. Outcomes will be stratified by payer status and ethnicity to determine the effect each of these variables has on outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02957331
Study type	Interventional
Source	University of Tennessee
Contact
Status	Completed
Phase	Phase 4
Start date	January 2016
Completion date	May 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04111549` - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth	N/A
Recruiting	`NCT05097261` - Ketamine in Acute Brain Injury Patients.	Phase 4
Completed	`NCT03504709` - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Recruiting	`NCT03899532` - Remote Ischemic Conditioning in Traumatic Brain Injury	N/A
Completed	`NCT05057377` - Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
Withdrawn	`NCT02776488` - Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)	Phase 2
Completed	`NCT02426749` - Treatment and Recovery Monitoring of Post TBI Symptoms	N/A
Completed	`NCT01339702` - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting	`NCT05977270` - The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury	N/A
Recruiting	`NCT04666766` - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers	N/A
Active, not recruiting	`NCT04559724` - Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes	N/A
Not yet recruiting	`NCT04515420` - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Not yet recruiting	`NCT05569993` - Glutamine and Traumatic Brain Injury	Early Phase 1
Recruiting	`NCT04331392` - Online Memory Intervention for Individuals With Traumatic Brain Injury	N/A
Completed	`NCT03727737` - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI	N/A
Completed	`NCT03153397` - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)	N/A
Completed	`NCT02004080` - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed	`NCT01336413` - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans	Phase 2
Completed	`NCT04957563` - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia	N/A
Completed	`NCT05179330` - Visual Feedback in Lower Limb Rehabilitation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.