- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01202110
Early Propranolol After Traumatic Brain Injury: Phase II (EPAT: Phase II)
May 12, 2016 updated by: Eric Ley, Cedars-Sinai Medical Center
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Routine care
|
|
Experimental: Propranolol
Propranolol 1mg iv
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
September 14, 2010
First Submitted That Met QC Criteria
September 14, 2010
First Posted (Estimate)
September 15, 2010
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
Other Study ID Numbers
- Pro00020850
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
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Queen Mary University of LondonCompleted
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Douglas Mental Health University InstituteInstitut de Recherche Robert-Sauvé en Santé et en Sécurité du TravailRecruitingTrauma and Stressor Related Disorders | Post-traumatic Stress Disorders | Adjustment Disorders | Acute Stress DisorderCanada
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