search
Back to results

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

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Propranolol

Control

Arm Description

Propranolol 1mg iv

Routine care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2010
Last Updated
May 12, 2016
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01202110
Brief Title
Early Propranolol After Traumatic Brain Injury: Phase II
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Propranolol 1mg iv
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Drug
Intervention Name(s)
Propranolol
Primary Outcome Measure Information:
Title
Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Early Propranolol After Traumatic Brain Injury: Phase II

We'll reach out to this number within 24 hrs