Early Propranolol After Traumatic Brain Injury: Phase II

NCT01202110 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-05-13

Study results available
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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.

Conditions

Interventions

DRUG

Propranolol

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202110 on ClinicalTrials.gov