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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Cedars-Sinai Medical Center
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01202110
First received: September 14, 2010
Last updated: June 21, 2011
Last verified: June 2010
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: Propranolol
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Determine in patients with traumatic brain injury (TBI) the safe dosing of early propranolol. [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propranolol Drug: Propranolol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202110

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Eric Ley       eric.ley@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Eric Ley, Department of Surgery
ClinicalTrials.gov Identifier: NCT01202110     History of Changes
Other Study ID Numbers: Pro00020850
Study First Received: September 14, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014