Early Propranolol After Traumatic Brain Injury: Phase II

Phase 2

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Propranolol

• Registration Number: NCT01202110
• Lead Sponsor: Cedars-Sinai Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-03-08
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-12
• Last Update Submitted: 2016-05-12
• Results First Posted: 2016-05-13
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propranolol	Propranolol	Propranolol 1mg iv

Primary Outcome Measures

Name	Time	Method
Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.	24 months	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States