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Traumatic Brain Injury | Early Propranolol After Traumatic Brain Injury: Phase II

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Propranolol

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropranololPropranolol 1mg iv

ControlRoutine care

Study Status

Terminated

Start Date: June 2010

Completed Date: February 2015

Phase: Phase 2

Type: Interventional

Design:

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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Cedars-Sinai Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01202110

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