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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT01322048
• Date of registration: 02/03/2011
• Primary sponsor: Vanderbilt University
• Public title: DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury
• Scientific title: DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Severe Traumatic Brain Injury, A Pilot Randomized Clinical Trial Using Propranolol and Clonidine
• Date of first enrolment: August 2011
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01322048
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mayur B Patel, MD, MPH

• Name: Mayur B Patel, MD, MPH

• Name: Mayur B Patel, MD, MPH
• Affiliation: Vanderbilt University

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Brain Injuries

Craniocerebral Trauma

Trauma, Nervous System

Traumatic Brain Injury

Intervention(s)

Drug: IV Propranolol and Per Tube Clonidine

Drug: Placebo

Primary Outcome(s)

Ventilator-free days [Time Frame: Baseline to hospital discharge (average t = Day 30)]

Secondary Outcome(s)

24h Urinary Catecholamine Levels [Time Frame: Baseline, Post-treatment (t=Day 8)]

Adjunct medication use [Time Frame: Baseline to hospital discharge (average t = Day 30)]

Average daily Agitation Behavior Scale (ABS) score [Time Frame: Twice daily to hospital discharge (average t = Day 30)]

Average daily Glasgow Coma Scale (GCS) score [Time Frame: Twice daily to hospital discharge (average t = Day 30)]

Cardiac Complications [Time Frame: Baseline to ICU discharge (average t = Day 14)]

Change in Low frequency to high frequency ratio from heart rate variability analysis [Time Frame: Post-treatment (t= Day 8 )]

Coma-free days [Time Frame: Baseline to hospital discharge (average t = Day 30)]

Daily percentage of low heart rate variability (HRV) intervals [Time Frame: Baseline to ICU Discharge (average t = Day 14)]

Daily pulse pressure variability [Time Frame: Baseline to ICU discharge (average t = Day 14)]

Extended Glasgow Outcome Scale (GOSE) [Time Frame: At 3 months, 12 months]

Hospital length of stay [Time Frame: Baseline to hospital discharge (average t = Day 30)]

ICU Length of Stay [Time Frame: Baseline to ICU discharge (average t = Day 14)]

Neuropsychological Assessment [Time Frame: At hospital discharge (average t = Day 30), 3 months, 12 months]

Percent RASS score within target range [Time Frame: Twice daily to hospital discharge (average t = Day 30)]

Plasma Catecholamine Levels [Time Frame: Baseline, Post-treatment (t=Day 8)]

Quality of Life after Brain Injury (QOLIBRI) [Time Frame: 3 months, 12 months]

Secondary ID(s)

110429

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vanderbilt Institute for Clinical and Translational Research (CTSA)