Early Propranolol After Traumatic Brain Injury: Phase II (EPAT: Phase II)

Cedars-Sinai Medical Center

Status and phase

Terminated

Phase 2

Conditions

Traumatic Brain Injury

Treatments

Drug: Propranolol

Study type

Interventional

Funder types

Other

Identifiers

NCT01202110

Pro00020850

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.