Phase 2
Completed N=47
DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury
Brain Injuries · Craniocerebral Trauma · Trauma, Nervous System · Traumatic Brain Injury
Source: ClinicalTrials.gov NCT01322048 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Ventilator-free Days — 16.2; 18.05 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilator-free Days |
16.2; 18.05 | — |
| SECONDARY Plasma Norepinephrine Levels |
962; 714 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01322048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.