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

Completed · Phase 2 · Has a placebo group

Conditions studied: Brain Injuries, Craniocerebral Trauma, Trauma, Nervous System, Traumatic Brain Injury

In brief

The investigators intend to determine the effect of adrenergic blockade on 1) short-term physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe Traumatic Brain Injury (TBI). The primary hypothesis is that adrenergic blockade after severe TBI will be associated with increased ventilator-free days.

Key facts

Study ID

NCT01322048

Run by

Vanderbilt University

People needed

48

Starts

2011-08-01

Expected to finish

2016-12-01

Last updated by the study team

2017-08-17

Who can join

Age: 16 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 16 years to 64 years
• Glasgow Coma Scale score less than or equal to 8 (Severe TBI) with injury on CT
• Screen within 24 hours of injury

You may not qualify if…

• Pre-existing heart disease (i.e. coronary heart disease)
• Pre-existing cardiac dysrhythmia
• Allergy to study drugs
• Penetrating brain injury
• Pre-existing brain dysfunction (i.e. prior severe TBI, debilitating stroke)
• Impending brain herniation (i.e. loss of bilateral corneal reflexes)
• Craniectomy or craniotomy
• Spinal cord injury
• Myocardial injury
• Severe liver disease
• Current use of beta-blockers and/or alpha-2-agonist
• Withdrawal of care expected in 24 hours
• Prisoners
• Pregnant women
• Unable to follow-up through final visit

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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