Trial Outcomes & Findings for DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury (NCT NCT01322048)

NCT ID: NCT01322048

Last Updated: 2017-08-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline to day 28
• Results posted on: 2017-08-17

Participant Flow

One subject was enrolled but was not randomized/assigned to either arm, due to a late withdrawal of care decision.

Participant milestones

Measure	Adrenergic Blockade Propranolol and Clonidine IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days	Placebo Placebo Placebo: Placebo IV q6h and Per Tube q12, both for 7 days
Overall Study STARTED	21	26
Overall Study COMPLETED	21	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury

Baseline characteristics by cohort

Measure	Adrenergic Blockade n=21 Participants Propranolol and Clonidine IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days	Placebo n=26 Participants Placebo Placebo: Placebo IV q6h and Per Tube q12, both for 7 days	Total n=47 Participants Total of all reporting groups
Age, Continuous	24 years n=93 Participants	27.5 years n=4 Participants	25 years n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	25 Participants n=4 Participants	41 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=93 Participants	26 Participants n=4 Participants	47 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	19 Participants n=93 Participants	24 Participants n=4 Participants	43 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	21 Participants n=93 Participants	26 Participants n=4 Participants	47 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to day 28

Outcome measures

Measure	Adrenergic Blockade n=21 Participants Propranolol and Clonidine IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days	Placebo n=26 Participants Placebo Placebo: Placebo IV q6h and Per Tube q12, both for 7 days
Ventilator-free Days	16.2 days Interval 5.5 to 20.1	18.05 days Interval 0.075 to 20.45

SECONDARY outcome

Timeframe: Post-treatment (t=Day 8)

Population: Of those surviving treatment period

Outcome measures

Measure	Adrenergic Blockade n=21 Participants Propranolol and Clonidine IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days	Placebo n=25 Participants Placebo Placebo: Placebo IV q6h and Per Tube q12, both for 7 days
Plasma Norepinephrine Levels	962 pg/mL Interval 508.0 to 1471.0	714 pg/mL Interval 391.0 to 1257.0

Adverse Events

Adrenergic Blockade

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mayur B. Patel

Vanderbilt University Medical Center

Phone: 6153225000

Email: mayur.b.patel@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place