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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Intervention Drug: Propranolol
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Propranolol
Hide Arm/Group Description Control Propranolol
Period Title: Overall Study
Started 10 0
Completed 10 0
Not Completed 0 0
Arm/Group Title Control
Hide Arm/Group Description Control
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
27.7  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
1.Primary Outcome
Title Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated prior to enrolling
Arm/Group Title Propranolol
Hide Arm/Group Description:
0
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control
Hide Arm/Group Description 10
All-Cause Mortality
Control
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Leah Silbert
Organization: Cedars-Sinai
Phone: 310 423-3783
Responsible Party: Eric Ley, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01202110     History of Changes
Other Study ID Numbers: Pro00020850
First Submitted: September 14, 2010
First Posted: September 15, 2010
Results First Submitted: March 8, 2016
Results First Posted: May 13, 2016
Last Update Posted: May 13, 2016