Trial Outcomes & Findings for Early Propranolol After Traumatic Brain Injury: Phase II (NCT NCT01202110)
NCT ID: NCT01202110
Last Updated: 2016-05-13
Results Overview
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.
TERMINATED
PHASE2
10 participants
24 months
2016-05-13
Participant Flow
Participant milestones
| Measure |
Control
Control
|
Propranolol
Propranolol
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
0
|
|
Overall Study
COMPLETED
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Propranolol After Traumatic Brain Injury: Phase II
Baseline characteristics by cohort
| Measure |
Control
n=10 Participants
Control
|
|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 11.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Terminated prior to enrolling
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.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place