Status:
TERMINATED
Early Propranolol After Traumatic Brain Injury: Phase II
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01202110
Start Date
June 1 2010
End Date
February 1 2015
Last Update
May 13 2016
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048