Phase 4 N=26 Randomized Treatment

Beta Blockade in in Traumatic Brain Injury

Brain Injuries, Traumatic

Bottom Line

View on ClinicalTrials.gov: NCT02957331 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Mortality — 7.7; 33.3 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Propranolol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Tennessee
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mortality	7.7; 33.3	—
SECONDARY Urine Catecholamine Levels	236.4; 278.0; 263.6; 181.9; 308.5; 200.1	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects ages 18 and older with isolated traumatic brain injury as defined by Glasgow Coma Scale score 12 or less with documented injury on head CT and limited injury to the rest of the body. (Abbreviated Injury Scale (AIS) must be 3).
Subjects who cannot be enrolled within 48 hours of admission following acute resuscitation will not be enrolled into this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02957331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.