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

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01202110
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Drug: Propranolol	Phase 2

Study Design

• Study Type: Interventional
• 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: Jun 1, 2010
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Ley, MD, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT01202110
• Other Study ID Numbers: Pro00020850
• First Posted: Sep 15, 2010
• Last Update Posted: May 13, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Propranolol

Study Results

Participant Flow

Arm/Group Title	Control	Propranolol
Arm/Group Description	Control	Propranolol
Period Title: Overall Study
STARTED	10	0
COMPLETED	10	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control
Arm/Group Description	Control
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.7 (11.4)
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Terminated prior to enrolling

Arm/Group Title	Propranolol
Arm/Group Description	0
Measure Participants	0

Adverse Events

Arm/Group Title	Control
Arm/Group Description	10
All Cause Mortality
	Control
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Control
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Control
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.