protocolSection identificationModule nctId: NCT06262061, orgStudyIdInfo id: PRO-TBI-FS, briefTitle: Propranolol for the Treatment of Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: London Health Sciences Centre, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: TBI (Traumatic Brain Injury), designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, single- center double- blinded randomized control trial comparing placebo to propranolol for the treatment of moderate- severe traumatic brain injury., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Patients will be randomized in a 1:1 allocation to either the propranolol or control group. Our hospital pharmacy will control the randomization procedure. The propranolol group will receive over-encapsulated whole marketed tablets comprised of 20mg oral propranolol \[USP grade\] filled with lactose monohydrate powder \[NF grade\] encapsulated with opaque gelatin capsules twice daily for 14 days (or until hospital discharge or death). The control group will receive an oral placebo comprised of lactose monohydrate powder \[NF grade\] encapsulated with indistinguishable opaque gelatin capsules. The pharmacy will have access to the randomization key. Nursing staff will remove the gelatin capsule casing and dissolve the trial drug \& placebo in sterile water prior to administering it enterally via a feeding tube to the participants. Aside from the nursing staff, the participants, research team, and remainder of the clinical care teams will all remain blinded to treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Propranolol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Hospital Mortality, primaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Catecholamines/Inflammatory markers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False