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Early Propranolol After Traumatic Brain Injury: Phase II

Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury

Intervention: Propranolol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Cedars-Sinai Medical Center

Summary

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.

Clinical Details

Official title: A Phase II, Dose Escalation, Single Center Study on the Effects of Early Propranolol on Heart Rate, Blood Pressure, and Cerebral Perfusion Pressure in Subjects Who Present With Moderate to Severe Traumatic Brain Injury.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine in patients with traumatic brain injury (TBI) the safe dosing of early propranolol.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Eric Ley, Email: eric.ley@cshs.org
Additional Information

Starting date: June 2010
Last updated: June 21, 2011

Page last updated: November 27, 2014

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