Traumatic Brain Injury
Conditions
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.
Interventions
DRUGPropranolol
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol. | 24 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Control |
|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: 24 months
Population: Terminated prior to enrolling