Early Propranolol After Traumatic Brain Injury: Phase II

Phase 2TerminatedNCT01202110

Cedars-Sinai Medical Center10 enrolled

Overview

The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate \< 60 beats per minute), hypotension (defined as systolic blood pressure \< 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

PropranololDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients who present within 6 hours of traumatic brain injury who have 1) a Glasgow Coma Scale (GCS) score of ≤8 or a GCS of 9-12 with computerized tomography brain scans demonstrating brain injury. Exclusion Criteria: * pregnancy, * patients already treated with beta-blockers, * patients treated for antiarrhythmic, immunosuppressive or antiinfective treatment, * myocardial infarction during the last 3 months, * unstable or severe heart disease, * severe chronic obstructive pulmonary disease, * serious liver disease, * cardiac ischemia that prevents the initiation of vasopressors, * signs of cardiac arrhythmia or heart block on EKG, * ischemic limb disease that prevents the initiation of vasopressors, vasopressors at maximum dose defined as norepinephrine at 40µg/min or neosynephrine at 300µg/min.

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.

The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate \< 60 beats per minute), hypotension (defined as systolic blood pressure \< 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment.

Time frame: 24 months

Data from ClinicalTrials.gov

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