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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborators: Eastern Association for the Surgery of Trauma (EAST); Vanderbilt Institute for Clinical and Translational Research (CTSA)
• Treatments: Adrenergic Agents; Clonidine; Propranolol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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