Early Propranolol After Traumatic Brain Injury: Phase II

Traumatic Brain Injury Clinical Trial

— EPAT: Phase II  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01202110
• Other study ID #: Pro00020850
• Status: Terminated
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: May 12, 2016
• Start date: June 2010
• Est. completion date: February 2015

Study information

• Verified date: May 2016
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• Propranolol

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.	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.	24 months	Yes