Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01202110
Status:
TERMINATED
Last Update Posted:
2016-05-13
First Post:
2010-09-14
Brief Title:
Early Propranolol After Traumatic Brain Injury Phase II
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPAT Phase II
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None