Early Propranolol After Traumatic Brain Injury: Phase II

NCT01202110 | Terminated Phase 2 Results DMC

• 1 other identifier: Pro00020850
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 months

Study Arms (2)

Propranolol

EXPERIMENTAL

Propranolol 1mg iv

Drug: Propranolol

Control

NO INTERVENTION

Routine care

Interventions

Propranolol DRUG

Propranolol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Leah Silbert
• Organization: Cedars-Sinai

Leah.Silbert@cshs.org

310 423-3783

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 13, 2016
• Results First Posted: May 13, 2016

Record last verified: 2016-05

Locations

US (1)