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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01202110
Recruitment Status : Terminated
First Posted : September 15, 2010
Results First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Eric Ley, 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Propranolol Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Propranolol
Propranolol 1mg iv
Drug: Propranolol
No Intervention: Control
Routine care



Primary Outcome Measures :
  1. Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202110


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center

Responsible Party: Eric Ley, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01202110     History of Changes
Other Study ID Numbers: Pro00020850
First Posted: September 15, 2010    Key Record Dates
Results First Posted: May 13, 2016
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents