Propranolol for the Treatment of Traumatic Brain Injury
Status: Not yet recruiting

Traumatic brain injury (TBI) is a leading cause of global disease and directly affects over 1.5 million Canadians, with 165 000 TBIs occurring yearly in Canada. Despite the burden of TBIs, there are limited treatment options available and current treatments generally focus on supportive care. The aim of TBI treatment is reduce inflammation and damage occurring after the TBI (secondary injury).

Beta- blockers (BBs) are medications commonly used to block the actions of endogenous catecholamines- hormones that are thought to contribute to secondary injury within brain tissue. This reduces metabolic demand in the vulnerable, injured brain. BBs have been studied in several retrospective trials and one single-center, non- blinded randomized controlled study. These results point towards a benefit to the use of BBs in TBI but need to be confirmed in a rigorous manner before they are widely adopted.

The current study aims to assess the feasibility of a single centre randomized controlled trial of BBs versus placebo to treat moderate to severe TBI. This feasibility trial will inform the planning of a large multi-center study powered to detect a difference in cognitive outcomes and mortality. It also will allow the investigators to gather biologic samples for measuring serum catecholamines and inflammatory mediators to better understand the basic science mechanisms of BBs in this patient population; and to assess the feasibility of using the Cambridge Battery to assess cognitive outcomes of trial participants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Adult patients (>18/= 18 years of age) who have sustained a TBI Initial GCS during the first 6 hours of assessment of 5- 12 (inclusive)  Exclusion Criteria  Home beta- blocker therapy New indication for beta- blocker therapy during hospital stay  Contraindication to beta- blocker therapy  Allergy Severe asthma/ COPD Sinus bradycardia and greater than first degree block Patients in cardiogenic shock Right ventricular failure secondary to pulmonary hypertension Congestive heart failure unless the failure is secondary to a tachyarrhythmia treatable with propranolol Patients requiring any vasoactive medications to maintain their blood pressure at the time of enrollment  Patients requiring or are on any of the following medications:  Digitalis Anesthetic agents that maintain cardiac contractility by virtue of their effect on catecholamine release (e.g., ether) Epinephrine, noradrenaline, adrenaline, and isoproterenol Antiarrhythmic cardiac depressant drugs such as procainamide or quinidine Thiazide-like diuretics and/or peripheral vasodilators Catecholamine depletion drugs such as reserpine or guanethidine Patients not expected to survive 48 hours  >24 hours from trauma at the time of enrollment  a. Patients on vasoactive medications at initial trial screening may enter the trial if their vasopressor requirements cease within 24 hours of their trauma  Inability to secure enteral access for medication administration  Doses of BB will be held under the following circumstances  a. HR <45 or MAP <55 for 5 minutes prior to administration time  Patients that are pregnant and/or breastfeeding participants - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult