A Phase 2 interventional study of Propranolol in Traumatic Brain Injury, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by Cedars-Sinai Medical Center · Phase 2, Interventional, and Treatment
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 10 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion Criteria:
Propranolol 1mg iv
Drug: Propranolol
Routine care
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
| Milestone | Control | Propranolol |
|---|---|---|
| Started | 10 | 0 |
| Completed | 10 | 0 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Control |
|---|---|
| Mean | 27.7 ± 11.4 |
| Sex: Female, Male(Participants) | Control |
|---|---|
| Female | 3 |
| Male | 7 |
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center