Early Propranolol After Traumatic Brain Injury: Phase II

NCT ID: NCT01202110

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-02-28

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Propranolol

Propranolol 1mg iv

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Control

Routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Propranolol

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Ley

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pro00020850

Identifier Type: -

Identifier Source: org_study_id